Venous Reflux
Conditions
Keywords
Venous reflux, Venous leg ulcer, Varicose Veins, Chronic Venous Insufficiency, VenaSeal, Endothermal Ablation, Surgical Stripping, Radiofrequency Ablation, Laser Ablation, Great Saphenous Vein (GSV), Small Saphenous Vein (SSV), Anterior Accessory Saphenous Vein, Venous Reflux Disease (VRD)
Brief summary
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease
Detailed description
The study is designed with two randomized studies and one single arm study. Two randomized studies are for CEAP 2-5 subjects: 1. VenaSeal vs. Surgical Stripping Study (outside of the United States only) 2. VenaSeal vs. ETA Study The single arm study is for CEAP 6 subjects with active venous leg ulcers (VLU): 1\. VLU Study
Interventions
DEVICEVenaSeal™ System
The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
DEVICEEndothermal Ablation (ETA)
ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
PROCEDURESurgical Stripping
Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.
Sponsors
Medtronic Endovascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is ≥18 years of age 2. Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for treatment, as confirmed by Duplex Ultrasound (DUS) 3. Eligibility for treatment: * VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™ system and ETA * VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the VenaSeal™ system and surgical stripping * VLU Study: patients should be eligible for treatment with the VenaSeal™ system 4. Treatable refluxing segment of target vein(s) 10 cm in length or longer 5. Patient has a target vein diameter of ≥3 mm throughout the intended treated segment of the target vein as measured by DUS while patient is standing 6. Patient is willing and capable of complying with specified follow-up evaluations at the specified times 7. Patient has an ability to understand the requirements of the study and to provide informed consent
Exclusion criteria
1. Patient has a known history of allergic sensitivities (including but not limited to cyanoacrylate adhesives), or any other condition, which in the opinion of the investigator may make the patient more susceptible to cyanoacrylate adhesive hypersensitivity 2. Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care 3. Patient has abnormal pulse exam or Ankle-Brachial Index (ABI) \<0.8 4. Patient has acute superficial thrombophlebitis 5. Patient requires any non-target vein treatments in the contralateral or ipsilateral limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months post-procedure 6. Patient has any co-morbid conditions, which in the investigator's opinion may interfere with the patient's compliance with study visits and procedures, or may confound interpretation of study data (e.g., congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy \< 1 year) 7. Instructions for Use (IFU) contraindications: * VenaSeal vs. ETA Study: Patient has VenaSeal™ system and/or ETA product's IFU contraindication(s) * VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or VenaSeal™ system IFU contraindication(s) * VLU Study: Patient has VenaSeal™ system IFU contraindication(s) 8. Patient is non-ambulatory 9. Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure 10. Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures 11. Patient is currently participating in an investigational drug or device study when the data collected could be conflicting or biased due to participation in another study 12. Patient has documented COVID-19 infection currently or within the past 3 months. Patient is not completely recovered from past COVID-19 infection, per physician's discretion. 13. VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory 14. VLU Study: Patient has target circumferential ulceration that cannot be captured in a single photograph (any ulcer curvature around the leg that goes out of sight)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days. | 30 days | Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure. | Post Index procedure, on the day of the procedure immediately following treatment | Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure. | Post Index procedure, on the day of the procedure immediately following treatment | Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated. |
| Single Arm Venous Leg Ulcer (VLU) Study: Primary Endpoint: Time to Ulcer Healing, Calculated Through Healing Confirmation and Verified by an Independent Core Laboratory Through 12 Months. | 12 months | Time to ulcer healing reported by using the cumulative incidence probability estimate of the event happening at 12 months, expressed as a percentage. The data values below represent the cumulative incidence probability as a percentage of participants with ulcer healing through 12 months. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days. | 30 days | Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days. | 30 days | Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days. | 30 days | Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | 12 months | — |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months. | 6 months | Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months. | 6 months | Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months. |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months. | 6 months | Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Time to Return to Work as Reported by the Patient. | 30 days | Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient. | 30 days | Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days. |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient. | 30 days | Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | 12 months | Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), Symptomatic deep vein thrombosis (DVT) events. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months. | 30 days and 12, 24, 36, 48 and 60 months | For subjects treated with the VenaSeal™ system or ETA it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12, 24, 36, 48 and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure at 30 days and 12, 24, 36, 48 and 60 months. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months. | 30 days, 12 months | Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months. |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months. | 30 days, 12 months, 24 months, 36 months, 48 months and 60 months | For subjects treated with the VenaSeal™ system it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 12 months, 24 months, 36 months, 48 months and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure tat 30 days, 12 months, 24 months, 36 months, 48 months and 60 months |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. | 30 days, and 6, 12, 24, 36, 48 and 60 months | For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, and 6, 12, 24, 36, 48 and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, and 6, 12, 24, 36, 48 and 60 months. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months. | 30 days, 6, 12 months | Anatomic closure of target superficial truncal vein defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months. |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. | 30 days, and 6, 12, 24, 36, 48 and 60 months. | For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, and 6, 12, 24, 36, 48 and 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure at 30 days, and 6, 12, 24, 36, 48 and 60 months. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure. | Post Index procedure, on the day of the procedure immediately following treatment | For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure. | Post Index procedure, on the day of the procedure immediately following treatment | Defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual vein after surgical stripping procedures. |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure. | Post Index procedure, on the day of the procedure immediately following treatment | For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months, Assessed at Each Follow-up Visit. | 12 months | — |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months, Assessed at Each Follow-up Visit. | 60 months | — |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months. | 12 months | As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 12 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 12 months. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients. | 30 days | Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients. | 30 days | Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days. |
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients. | 30 days | Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days | Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days | Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable. |
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days | Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 7 and 30 days, and at 6, 12, 24, 36 and 60 months | Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline. | 7 and 30 days, and at 6 and 12 months | Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames. |
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 7 and 30 days, and at 6, 12, 24, 36 and 60 months | Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Aberdeen Varicose Vein Questionnaire (AVVQ) Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days, and at 6, 12, 24, 36, 48 and 60 months | The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline. | 30 days, and 6 and 12 months | The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames. |
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days, and at 6, 12, 24, 36 and 60 months | The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline. | 30 days, and 6, 12, 24, 36, 48 and 60 months | EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline. | 30 days, and 6 and 12 months | EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames. |
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline. | 30 days, and 6, 12, 24, 36, 48 and 60 months | EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | 30 days, and 6 and 12 months | The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | 30 days, and 6 and 12 months | The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames. |
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | 30 days, and 6 and 12 months | The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days, and 6, 12, 24, 36, 48, and 60 months | The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad). The outcome measure data reports the responses at the different time points compared to baseline. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days, and 6, 12 months | The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad). The outcome measure data reports the responses at the different time points compared to baseline. |
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days, and 6, 12, 24, 36, 48, and 60 months | The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad). The outcome measure data reports the responses at the different time points compared to baseline. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Post-index procedure, on the day of the procedure immediately following treatment | Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment). |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Post-index procedure, on the day of the procedure immediately following treatment | Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment). |
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Post-index procedure, on the day of the procedure immediately following treatment | Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment). |
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days. | 30 days | Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction. |
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days. | 30 days | Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction. |
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Target Vein at the Time of Index Procedure as Measured by the Percentage of Target Veins Successfully Treated. | Post-index procedure, on the day of the procedure immediately following treatment | Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated. |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months, Assessed at Each Follow-up Visit. | 60 months | — |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. | 60 months | Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 60 months |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. | 60 months | Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 60 months. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 60 Months. | 60 months | — |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 60 Months. | 60 months | — |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months. | 60 months | As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 60 months. |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months. | 60 months | As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 60 months. |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Time to Ulcer Recurrence on the Target Limb Following Ulcer Healing Through 60 Months. | 60 months | Time to ulcer recurrence reported by using the cumulative incidence probability estimate of the event happening at 60 months, expressed as a percentage. Ulcer recurrence could only occur after the initial ulcer had completely healed. |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Ulcer Free Time, Calculated as Days Between Initial Ulcer Healing and First Ulcer Recurrence, as Applicable, Through 60 Months. | 60 months | As measured by the time between initial ulcer healing and the first ulcer recurrence. |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Ulcer Healing Rate, as Measured by the Percentage of the Ulcer Area Healed, Through 24 Months. | 24 months | Ulcer healing rate, as measured by the percentage of the ulcer area healed, according to an independent core laboratory through 24 months or until ulcer healing has been confirmed. This was assessed by overall number of wound care utilizations, and also by different wound care treatments subtypes. |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Healthcare Utilization and Routine Wound Care Treatments Between Study Visits Through 60 Months. | 60 months | Determined by the number of ulcer wound care treatments utilized between study visits through 60 months. |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Additional Events Evaluated Through 60 Months. | 60 Months | Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs). |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | 12 months | Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events. |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Additional Events Evaluated Through 60 Months. | 60 Months | Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs). |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | 12 months | Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events. |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months. | 12 months | Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs). |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. | 12 months | — |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. | 12 months | — |
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. | 12 months | — |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. | 12 months | Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 12 months. |
Countries
Australia, Canada, France, Germany, Italy, Netherlands, South Korea, Spain, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORKathleen Gibson, MD
Lake Washington Vascular, US
PRINCIPAL_INVESTIGATORManjit Gohel, MD
Addenbrooke's Hospital, UK
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA
VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein. | 136 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA
Endothermal Ablation (ETA): ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein.
Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice. | 139 |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping
VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein. | 53 |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping
Surgical Stripping: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures. | 53 |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System
VenaSeal™ System: The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein. | 125 |
| Total | 506 |
Baseline characteristics
| Characteristic | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 57.0 years STANDARD_DEVIATION 13.2 | 57.2 years STANDARD_DEVIATION 13.7 | 60.3 years STANDARD_DEVIATION 14.39 | 61.5 years STANDARD_DEVIATION 12.96 | 67.9 years STANDARD_DEVIATION 14.76 | 60.7 years STANDARD_DEVIATION 14.52 |
| Body Mass Index | 26.4 kg/m2 STANDARD_DEVIATION 4.92 | 27.9 kg/m2 STANDARD_DEVIATION 5.77 | 25.8 kg/m2 STANDARD_DEVIATION 5.77 | 24.2 kg/m2 STANDARD_DEVIATION 3.41 | 32.4 kg/m2 STANDARD_DEVIATION 9.35 | 28.1 kg/m2 STANDARD_DEVIATION 7.08 |
| CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C0 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C1 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C2 | 43 Participants | 48 Participants | 22 Participants | 23 Participants | 0 Participants | 136 Participants |
| CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C3 | 61 Participants | 53 Participants | 17 Participants | 18 Participants | 0 Participants | 149 Participants |
| CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C4a | 28 Participants | 25 Participants | 12 Participants | 9 Participants | 0 Participants | 74 Participants |
| CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C4b | 4 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants | 11 Participants |
| CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C5 | 0 Participants | 9 Participants | 1 Participants | 1 Participants | 0 Participants | 11 Participants |
| CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification C6 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 125 Participants | 125 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Chinese | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Japanese | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Korean | 13 Participants | 14 Participants | 38 Participants | 41 Participants | 0 Participants | 106 Participants |
| Race/Ethnicity, Customized Native American or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not reportable per local laws or regulations | 67 Participants | 69 Participants | 7 Participants | 4 Participants | 55 Participants | 202 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Subject declines to answer | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 50 Participants | 42 Participants | 5 Participants | 3 Participants | 63 Participants | 163 Participants |
| Sex/Gender, Customized Female | 91 Participants | 78 Participants | 29 Participants | 33 Participants | 48 Participants | 279 Participants |
| Sex/Gender, Customized Male | 40 Participants | 52 Participants | 21 Participants | 16 Participants | 77 Participants | 206 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 136 | 1 / 139 | 0 / 53 | 0 / 53 | 18 / 125 |
| other Total, other adverse events | 23 / 136 | 8 / 139 | 9 / 53 | 4 / 53 | 50 / 125 |
| serious Total, serious adverse events | 12 / 136 | 11 / 139 | 1 / 53 | 4 / 53 | 55 / 125 |
Outcome results
Primary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.
Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
Time frame: Post Index procedure, on the day of the procedure immediately following treatment
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure. | 92.4 % of vein length | Standard Deviation 13.4 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure. | 91.1 % of vein length | Standard Deviation 11.85 |
Primary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days. | 31.8 score on a scale | Standard Deviation 5.12 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days. | 32.1 score on a scale | Standard Deviation 4.95 |
Primary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days. | 30.8 score on a scale | Standard Deviation 4.22 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days. | 29.6 score on a scale | Standard Deviation 4.73 |
Primary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.
Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
Time frame: Post Index procedure, on the day of the procedure immediately following treatment
Population: Target Veins based measurement. Number of units analyzed units corresponds to number of target veins with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure. | 69.9 % of vein length | Standard Deviation 19.93 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure. | 68.2 % of vein length | Standard Deviation 25.82 |
Primary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days. | 30.1 score on a scale | Standard Deviation 6.39 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days. | 28.3 score on a scale | Standard Deviation 5.58 |
Primary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days. | 29.3 score on a scale | Standard Deviation 4.94 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days. | 25.0 score on a scale | Standard Deviation 6.24 |
Primary
Single Arm Venous Leg Ulcer (VLU) Study: Primary Endpoint: Time to Ulcer Healing, Calculated Through Healing Confirmation and Verified by an Independent Core Laboratory Through 12 Months.
Time to ulcer healing reported by using the cumulative incidence probability estimate of the event happening at 12 months, expressed as a percentage. The data values below represent the cumulative incidence probability as a percentage of participants with ulcer healing through 12 months.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Primary Endpoint: Time to Ulcer Healing, Calculated Through Healing Confirmation and Verified by an Independent Core Laboratory Through 12 Months. | 81.3 percentage probability |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.
Time frame: 6 months
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months. | 93.9 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months. | 93.5 percentage probability |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.
Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Time to Return to Work as Reported by the Patient. | 97.9 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Time to Return to Work as Reported by the Patient. | 97.6 percentage probability |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.
Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), Symptomatic deep vein thrombosis (DVT) events.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Phlebitis | 12 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | EGIT/EHIT | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Granuloma | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | DVT | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Hypersensitivity to VenaSeal™ adhesive | 8 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | DVT | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Hypersensitivity to VenaSeal™ adhesive | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Phlebitis | 4 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Granuloma | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | EGIT/EHIT | 5 Participants |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.
For subjects treated with the VenaSeal™ system or ETA it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.
Time frame: 30 days and 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months. | 30 days | 95.4 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months. | 12 months | 86.6 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months. | 30 days | 95.2 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months. | 12 months | 89.3 percentage probability |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.
For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.
Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with data available at the index procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. | 30 days | 95.7 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. | 6 months | 93.5 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. | 12 months | 86.6 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. | 30 days | 94.6 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. | 6 months | 93.1 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. | 12 months | 89.0 percentage probability |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days change from baseline | -5.4 score on a scale | Standard Deviation 7.88 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months change from baseline | -7.8 score on a scale | Standard Deviation 7.77 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months change from baseline | -8.0 score on a scale | Standard Deviation 7.68 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days change from baseline | -2.5 score on a scale | Standard Deviation 8.19 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months change from baseline | -6.1 score on a scale | Standard Deviation 8.88 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months change from baseline | -6.6 score on a scale | Standard Deviation 10.37 |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.
EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline. | 30 days change from baseline | 0.10 score on a scale | Standard Deviation 0.14 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline. | 6 months change from baseline | 0.09 score on a scale | Standard Deviation 0.14 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline. | 12 months change from baseline | 0.08 score on a scale | Standard Deviation 0.16 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline. | 30 days change from baseline | 0.08 score on a scale | Standard Deviation 0.15 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline. | 6 months change from baseline | 0.08 score on a scale | Standard Deviation 0.18 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline. | 12 months change from baseline | 0.08 score on a scale | Standard Deviation 0.15 |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.
The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6 and 12 months
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 30 days change from baseline | 2.5 score on a scale | Standard Deviation 5.86 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 30 days change from baseline | 2.1 score on a scale | Standard Deviation 9.35 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 6 months change from baseline | 2.9 score on a scale | Standard Deviation 6.62 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 6 months change from baseline | 2.4 score on a scale | Standard Deviation 9.77 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 12 months change from baseline | 3.1 score on a scale | Standard Deviation 6.85 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 12 months change from baseline | 2.5 score on a scale | Standard Deviation 8.65 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 12 months change from baseline | 1.7 score on a scale | Standard Deviation 5.93 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 30 days change from baseline | 1.8 score on a scale | Standard Deviation 5.43 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 6 months change from baseline | 1.3 score on a scale | Standard Deviation 8.41 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 30 days change from baseline | 0.9 score on a scale | Standard Deviation 8.9 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 12 months change from baseline | 1.0 score on a scale | Standard Deviation 8.28 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 6 months change from baseline | 2.1 score on a scale | Standard Deviation 5.46 |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
Subjects answer their general quality of life with potential responses on an ordinal scale: excellent, very good, good, neither good nor bad, bad, very bad, or extremely bad. Subjects also answer what their quality of life would be without varicose veins with potential responses on an ordinal scale: very much better, much better, a little better, the same, or worse. The outcome measure data reports the responses at the different time frames including baseline.
Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Population: Overall Number of Participants Analyzed is the number of participants with data at baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Excellent | 22 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Very Good | 39 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Good | 44 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Neither Good Nor Bad | 16 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Bad | 7 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Very Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Very Much Better | 32 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Much Better | 45 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: A Little Better | 30 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: The Same | 15 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Excellent | 16 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Very Good | 48 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Good | 40 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Neither Good Nor Bad | 7 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Bad | 3 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Very Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Very Much Better | 28 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Much Better | 30 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: A Little Better | 40 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: The Same | 22 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Quality of Life: Excellent | 27 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Quality of Life: Very Good | 51 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Quality of Life: Good | 35 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Quality of Life: Neither Good Nor Bad | 3 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Quality of Life: Bad | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Quality of Life: Very Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: Very Much Better | 27 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: Much Better | 36 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: A Little Better | 30 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: The Same | 25 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Excellent | 24 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Very Good | 49 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Good | 34 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Neither Good Nor Bad | 5 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Bad | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Very Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: Very Much Better | 25 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: Much Better | 25 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: A Little Better | 28 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: The Same | 35 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: Worse | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: The Same | 34 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Excellent | 16 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Quality of Life: Excellent | 21 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Very Good | 32 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Excellent | 13 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Good | 49 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Quality of Life: Very Good | 47 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Neither Good Nor Bad | 17 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Bad | 6 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Quality of Life: Good | 32 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Very Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Very Good | 41 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Quality of Life: Neither Good Nor Bad | 8 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Very Much Better | 28 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: A Little Better | 26 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Much Better | 42 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Quality of Life: Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: A Little Better | 37 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Good | 36 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: The Same | 14 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Quality of Life: Very Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: Very Much Better | 14 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Excellent | 14 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Very Good | 47 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Neither Good Nor Bad | 12 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Good | 39 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: Very Much Better | 17 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Neither Good Nor Bad | 11 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: Worse | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Bad | 3 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: Much Better | 27 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Very Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: A Little Better | 26 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Very Much Better | 15 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: Much Better | 27 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Much Better | 33 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: The Same | 39 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: A Little Better | 31 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months Quality of Life: Very Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: The Same | 35 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: Worse | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Worse | 1 Participants |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 7 and 30 days, and at 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 7 days change from baseline | -2.2 score on a scale | Standard Deviation 2.76 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days change from baseline | -3.4 score on a scale | Standard Deviation 2.63 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months change from baseline | -4.3 score on a scale | Standard Deviation 2.52 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months change from baseline | -3.9 score on a scale | Standard Deviation 2.7 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months change from baseline | -3.8 score on a scale | Standard Deviation 2.93 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 7 days change from baseline | -1.4 score on a scale | Standard Deviation 2.51 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months change from baseline | -3.6 score on a scale | Standard Deviation 2.84 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days change from baseline | -3.1 score on a scale | Standard Deviation 2.7 |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.
Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
Time frame: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | Intra-procedure | 2.0 score on a scale | Standard Deviation 2.13 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | Post-procedure | 1.1 score on a scale | Standard Deviation 1.35 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | 7 days | 1.1 score on a scale | Standard Deviation 1.58 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | 30 days | 0.6 score on a scale | Standard Deviation 1.05 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | 30 days | 0.7 score on a scale | Standard Deviation 1.23 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | Intra-procedure | 2.7 score on a scale | Standard Deviation 2.41 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | 7 days | 1.0 score on a scale | Standard Deviation 1.4 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | Post-procedure | 1.2 score on a scale | Standard Deviation 1.73 |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.
Time frame: 12 months
Population: Rate based measurement; rate corresponds to the count of adjunctive procedures over the total vein-years (sum of patient follow-up time until adjunct procedure, 12 months, or exit if before 12 months, multiplied by number of target veins) among all target veins in the ITT cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. | Phlebectomy | 0.02 adjunctive treatment per vein-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. | Sclerotherapy | 0.1 adjunctive treatment per vein-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. | Phlebectomy | 0.01 adjunctive treatment per vein-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. | Sclerotherapy | 0.08 adjunctive treatment per vein-years |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.
Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
Time frame: Post-index procedure, on the day of the procedure immediately following treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Neutral | 4 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Dissatisfied | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Satisfied | 49 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Extremely Dissatisfied | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Extremely Satisfied | 77 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Extremely Dissatisfied | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Extremely Satisfied | 71 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Satisfied | 52 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Dissatisfied | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Neutral | 1 Participants |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.
For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
Time frame: Post Index procedure, on the day of the procedure immediately following treatment
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure. | 136 Target Veins |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure. | 129 Target Veins |
Secondary
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.
Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients. | 98.5 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients. | 96.8 percentage probability |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.
Time frame: 6 months
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months. | 97.9 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months. | 92.9 percentage probability |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.
Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient. | 89.0 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient. | 76.5 percentage probability |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months.
Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months. | Symptomatic pulmonary embolism (PE) | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months. | Serious adverse events (SAEs) | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months. | Symptomatic pulmonary embolism (PE) | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months. | Serious adverse events (SAEs) | 2 Participants |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.
Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Phlebitis | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | EGIT | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Granuloma | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | DVT | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Hypersensitivity to VenaSeal™ adhesive | 6 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | DVT | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Hypersensitivity to VenaSeal™ adhesive | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Phlebitis | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Granuloma | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | EGIT | 0 Participants |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months.
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.
Time frame: 30 days, 12 months
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months. | 30 days | 97.9 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months. | 12 months | 95.7 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months. | 30 days | 97.7 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months. | 12 months | 92.9 percentage probability |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months.
Anatomic closure of target superficial truncal vein defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.
Time frame: 30 days, 6, 12 months
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with data available at the index procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months. | 30 days | 98.0 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months. | 6 months | 98.0 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months. | 12 months | 96.0 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months. | 30 days | 97.8 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months. | 6 months | 93.2 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months. | 12 months | 93.2 percentage probability |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline.
The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6 and 12 months
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline. | 30 days change from baseline | -4.7 score on a scale | Standard Deviation 5.94 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline. | 6 months change from baseline | -7.0 score on a scale | Standard Deviation 6.26 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline. | 12 months change from baseline | -7.3 score on a scale | Standard Deviation 6.13 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline. | 30 days change from baseline | -1.0 score on a scale | Standard Deviation 8.89 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline. | 6 months change from baseline | -7.7 score on a scale | Standard Deviation 7.97 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline. | 12 months change from baseline | -8.8 score on a scale | Standard Deviation 6.62 |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline.
EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6 and 12 months
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline. | 30 days change from baseline | 0.12 score on a scale | Standard Deviation 0.19 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline. | 6 months change from baseline | 0.13 score on a scale | Standard Deviation 0.19 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline. | 12 months change from baseline | 0.12 score on a scale | Standard Deviation 0.22 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline. | 30 days change from baseline | 0.15 score on a scale | Standard Deviation 0.24 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline. | 6 months change from baseline | 0.13 score on a scale | Standard Deviation 0.24 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline. | 12 months change from baseline | 0.14 score on a scale | Standard Deviation 0.28 |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.
The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6 and 12 months
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 30 days change from baseline | 3.0 score on a scale | Standard Deviation 6.5 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 30 days change from baseline | 3.4 score on a scale | Standard Deviation 9.18 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 6 months change from baseline | 3.2 score on a scale | Standard Deviation 6.39 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 6 months change from baseline | 3.4 score on a scale | Standard Deviation 8.21 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 12 months change from baseline | 3.7 score on a scale | Standard Deviation 7.71 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 12 months change from baseline | 1.8 score on a scale | Standard Deviation 11.55 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 12 months change from baseline | 2.9 score on a scale | Standard Deviation 7.08 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 30 days change from baseline | 0.5 score on a scale | Standard Deviation 6.42 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 6 months change from baseline | 1.6 score on a scale | Standard Deviation 8.23 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 30 days change from baseline | 2.1 score on a scale | Standard Deviation 11.05 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 12 months change from baseline | 0.2 score on a scale | Standard Deviation 9.71 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 6 months change from baseline | 1.4 score on a scale | Standard Deviation 6.15 |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline.
Subjects answer their general quality of life with potential responses on an ordinal scale: excellent, very good, good, neither good nor bad, bad, very bad, or extremely bad. Subjects also answer what their quality of life would be without varicose veins with potential responses on an ordinal scale: very much better, much better, a little better, the same, or worse. The outcome measure data reports the responses at the different time frames including baseline.
Time frame: 30 days, and 6, 12 months
Population: Overall Number of Participants Analyzed is the number of participants with data at baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Excellent | 5 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Very Good | 12 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Good | 23 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Neither Good Nor Bad | 6 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Bad | 6 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Very Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Extremely Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Very Much Better | 23 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Much Better | 20 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: A Little Better | 5 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: The Same | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Excellent | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Very Good | 17 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Good | 21 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Neither Good Nor Bad | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Very Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Very Much Better | 16 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Much Better | 19 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: A Little Better | 7 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: The Same | 4 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Excellent | 7 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Very Good | 17 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Good | 15 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Neither Good Nor Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Very Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: Very Much Better | 13 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: Much Better | 19 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: A Little Better | 6 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: The Same | 3 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Excellent | 8 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Very Good | 16 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Good | 12 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Neither Good Nor Bad | 6 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Very Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: Very Much Better | 11 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: Much Better | 19 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: A Little Better | 10 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: The Same | 3 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: The Same | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Excellent | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Excellent | 3 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Very Good | 7 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Excellent | 4 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Good | 17 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Very Good | 6 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Neither Good Nor Bad | 12 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Bad | 4 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Good | 23 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Very Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Very Good | 9 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Quality of Life: Extremely Bad | 4 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Neither Good Nor Bad | 6 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Very Much Better | 18 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: A Little Better | 9 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Much Better | 20 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: A Little Better | 7 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Good | 15 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: The Same | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Very Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: Very Much Better | 12 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Excellent | 3 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Quality of Life: Extremely Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Very Good | 11 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Neither Good Nor Bad | 6 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Good | 20 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: Very Much Better | 15 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Neither Good Nor Bad | 4 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Bad | 3 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: Much Better | 17 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Very Bad | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Bad | 5 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: A Little Better | 7 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Very Much Better | 15 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Predicted QoL without Varicose Veins: Much Better | 17 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Much Better | 24 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: The Same | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: A Little Better | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 12 months Quality of Life: Very Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: The Same | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 6 months Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Worse | 0 Participants |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline.
Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 7 and 30 days, and at 6 and 12 months
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline. | 7 days change from baseline | -2.4 score on a scale | Standard Deviation 1.9 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline. | 30 days change from baseline | -3.2 score on a scale | Standard Deviation 1.78 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline. | 6 months change from baseline | -3.4 score on a scale | Standard Deviation 1.79 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline. | 12 months change from baseline | -3.6 score on a scale | Standard Deviation 2.16 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline. | 12 months change from baseline | -3.6 score on a scale | Standard Deviation 2.56 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline. | 7 days change from baseline | -1.6 score on a scale | Standard Deviation 2.63 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline. | 6 months change from baseline | -3.0 score on a scale | Standard Deviation 2.72 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline. | 30 days change from baseline | -2.2 score on a scale | Standard Deviation 2.45 |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.
Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 12 months.
Time frame: 12 months
Population: Rate based measurement; rate corresponds to the count of healthcare utilization over the total person-years (sum of patient follow-up time until Health Care Utilization, 12 months, or exit if before 12 months) among patients in the ITT cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. | Inpatient Visits | 0.0210 services utilized per person-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. | Hospital Outpatient Visits | 0.4409 services utilized per person-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. | Clinic Visits | 0.0840 services utilized per person-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. | Outpatient ER Visits | 0.0210 services utilized per person-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. | Outpatient ER Visits | 0.0228 services utilized per person-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. | Inpatient Visits | 0.0228 services utilized per person-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. | Clinic Visits | 0.1824 services utilized per person-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD. | Hospital Outpatient Visits | 0.1596 services utilized per person-years |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.
Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
Time frame: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | Intra-procedure | 1.6 score on a scale | Standard Deviation 2.25 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | Post-procedure | 1.5 score on a scale | Standard Deviation 1.97 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | 7 days | 2.1 score on a scale | Standard Deviation 2.24 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | 30 days | 1.5 score on a scale | Standard Deviation 1.92 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | 30 days | 2.3 score on a scale | Standard Deviation 2.39 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | Intra-procedure | 0.8 score on a scale | Standard Deviation 1.95 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | 7 days | 2.2 score on a scale | Standard Deviation 2.1 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | Post-procedure | 0.9 score on a scale | Standard Deviation 2 |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.
Time frame: 12 months
Population: Rate based measurement; rate corresponds to the count of adjunctive procedures over the total vein-years (sum of patient follow-up time until adjunct procedure, 12 months, or exit if before 12 months, multiplied by number of target veins) among all target veins in the ITT cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. | Phlebectomy | 0.07 adjunctive treatment per vein-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. | Sclerotherapy | 0.07 adjunctive treatment per vein-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. | Phlebectomy | 0 adjunctive treatment per vein-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. | Sclerotherapy | 0.02 adjunctive treatment per vein-years |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Diagnostic Tests Performed: Venogram | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Diagnostic Tests Performed: Computed Tomographic Venography | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Diagnostic Tests Performed: DUS | 4 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Diagnostic Tests Performed: Intravascular Ultrasound | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Diagnostic Tests Performed: Magnetic Resonance Venography | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Diagnostic Tests Performed: Other | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Actions Taken: Medication Change | 9 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Actions Taken: Intervention Involving Target Limb/Vein | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Hospitalization | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Other Actions | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Actions Taken: Intervention Involving Target Limb/Vein | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Diagnostic Tests Performed: Other | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Diagnostic Tests Performed: Computed Tomographic Venography | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Other Actions | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Diagnostic Tests Performed: DUS | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Actions Taken: Medication Change | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Diagnostic Tests Performed: Intravascular Ultrasound | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Hospitalization | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Diagnostic Tests Performed: Magnetic Resonance Venography | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months. | Diagnostic Tests Performed: Venogram | 0 Participants |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.
Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
Time frame: Post-index procedure, on the day of the procedure immediately following treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Extremely Satisfied | 10 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Dissatisfied | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Satisfied | 38 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Extremely Dissatisfied | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Neutral | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Extremely Dissatisfied | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Extremely Satisfied | 4 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Neutral | 9 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Dissatisfied | 3 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Satisfied | 27 Participants |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months, Assessed at Each Follow-up Visit.
Time frame: 12 months
Population: Rate based measurement; rate corresponds to count of reinterventions over the total vein-years (sum of patient follow-up time until reintervention, 12 months, or exit if before 12 months, multiplied by number of target veins) among all target veins in the ITT cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months, Assessed at Each Follow-up Visit. | 0.06 reintervention per vein-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months, Assessed at Each Follow-up Visit. | 0 reintervention per vein-years |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.
Defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual vein after surgical stripping procedures.
Time frame: Post Index procedure, on the day of the procedure immediately following treatment
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure. | 49 Target Veins |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure. | 44 Target Veins |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months.
As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 12 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 12 months.
Time frame: 12 months
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months. | 93.1 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months. | 100 percentage probability |
Secondary
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.
Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients. | 95.8 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients. | 93.0 percentage probability |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days change from baseline | -8.1 score on a scale | Standard Deviation 13.67 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months change from baseline | -13.4 score on a scale | Standard Deviation 14.4 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months change from baseline | -15.5 score on a scale | Standard Deviation 15.21 |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.
EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline. | 30 days change from baseline | 0.15 score on a scale | Standard Deviation 0.24 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline. | 6 months change from baseline | 0.15 score on a scale | Standard Deviation 0.25 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline. | 12 months change from basline | 0.17 score on a scale | Standard Deviation 0.25 |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.
The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6 and 12 months
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 30 days change from baseline | 2.20 score on a scale | Standard Deviation 7.17 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 30 days change from baseline | 3.60 score on a scale | Standard Deviation 12.13 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 6 months change from baseline | 2.86 score on a scale | Standard Deviation 7.77 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 6 months change from baseline | 5.82 score on a scale | Standard Deviation 10.67 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Physical Scale 12 months change from baseline | 3.80 score on a scale | Standard Deviation 8.23 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline. | Mental Scale 12 months change from baseline | 5.81 score on a scale | Standard Deviation 11.63 |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
Subjects answer their general quality of life with potential responses on an ordinal scale: excellent, very good, good, neither good nor bad, bad, very bad, or extremely bad. Subjects also answer what their quality of life would be without varicose veins with potential responses on an ordinal scale: very much better, much better, a little better, the same, or worse. The outcome measure data reports the responses at the different time frames including baseline.
Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Population: Overall Number of Participants Analyzed is the number of participants with data at baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Excellent | 8 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Very Good | 21 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Good | 36 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Neither Good Nor Bad | 33 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Bad | 20 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Very Bad | 4 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Quality of Life: Extremely Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Very Much Better | 52 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Much Better | 47 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: A Little Better | 19 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: The Same | 5 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | baseline Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Excellent | 5 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Very Good | 36 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Good | 42 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Neither Good Nor Bad | 24 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Bad | 10 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Very Bad | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Very Much Better | 29 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Much Better | 58 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: A Little Better | 20 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: The Same | 11 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Quality of Life: Excellent | 10 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Quality of Life: Very Good | 29 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Quality of Life: Neither Good Nor Bad | 16 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Quality of Life: Good | 35 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Quality of Life: Bad | 6 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Quality of Life: Very Bad | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Predicted QoL without Varicose Veins: Very Much Better | 27 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Predicted QoL without Varicose Veins: Much Better | 35 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Predicted QoL without Varicose Veins: A Little Better | 12 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Predicted QoL without Varicose Veins: The Same | 24 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 Months Predicted QoL without Varicose Veins: Worse | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 Months Quality of Life: Excellent | 8 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 Months Quality of Life: Very Good | 25 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 Months Quality of Life: Good | 30 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 Months Quality of Life: Neither Good Nor Bad | 13 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 Months Quality of Life: Bad | 7 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 Months Quality of Life: Very Bad | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 Months Quality of Life: Extremely Bad | 0 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 Months Predicted QoL without Varicose Veins: Very Much Better | 19 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 Months Predicted QoL without Varicose Veins: Much Better | 22 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 Months Predicted QoL without Varicose Veins: A Little Better | 19 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 Months Predicted QoL without Varicose Veins: The Same | 24 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 Months Predicted QoL without Varicose Veins: Worse | 1 Participants |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 7 and 30 days, and at 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 7 days change from baseline | -3.3 score on a scale | Standard Deviation 3.96 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 30 days change from baseline | -5.5 score on a scale | Standard Deviation 5.01 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 6 months change from baseline | -8.7 score on a scale | Standard Deviation 5.27 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline. | 12 months change from baseline | -9.0 score on a scale | Standard Deviation 5.44 |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Target Vein at the Time of Index Procedure as Measured by the Percentage of Target Veins Successfully Treated.
Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
Time frame: Post-index procedure, on the day of the procedure immediately following treatment
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Target Vein at the Time of Index Procedure as Measured by the Percentage of Target Veins Successfully Treated. | 90.8 % of vein length | Standard Deviation 13.21 |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.
Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
Time frame: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days
Population: Overall Number of Participants Analyzed is the number of participants that were treated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | Intra-procedure | 3.6 score on a scale | Standard Deviation 2.88 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | Post-procedure | 2.3 score on a scale | Standard Deviation 2.36 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | 7 days | 2.1 score on a scale | Standard Deviation 2.27 |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days. | 30 days | 1.8 score on a scale | Standard Deviation 2.32 |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.
Time frame: 12 months
Population: Rate based measurement; rate corresponds to the count of adjunctive procedures over the total vein-years (sum of patient follow-up time until adjunct procedure, 12 months, or exit if before 12 months, multiplied by number of target veins) among all target veins in the ITT cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. | Sclerotherapy | 0.12 adjunctive treatment per vein-years |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure. | Phlebectomy | 0 adjunctive treatment per vein-years |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days. | 30.9 score on a scale | Standard Deviation 4.87 |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days. | 28.2 score on a scale | Standard Deviation 6.17 |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.
Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
Time frame: Post-index procedure, on the day of the procedure immediately following treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Extremely Satisfied | 62 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Satisfied | 57 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Neutral | 4 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Dissatisfied | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure. | Physician Satisfaction with Procedure: Extremely Dissatisfied | 0 Participants |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.
Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients. | 80.9 percentage probability |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.
Time frame: 6 months
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months. | 87.3 percentage probability |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.
Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient. | 85.7 percentage probability |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.
Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Hypersensitivity to VenaSeal™ adhesive | 1 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Phlebitis | 13 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | Granuloma | 2 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | EGIT | 3 Participants |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months. | DVT | 2 Participants |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.
For subjects treated with the VenaSeal™ system it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.
Time frame: 30 days and 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of primary target veins with data available at the index procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months. | 30 days | 91.9 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months. | 12 months | 82.3 percentage probability |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.
For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.
Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Population: Target Veins based measurement. Number of units analyzed corresponds to the number of target veins with data available at the index procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. | 30 days | 93.6 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. | 6 months | 89.1 percentage probability |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months. | 12 months | 85.2 percentage probability |
Secondary
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.
For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
Time frame: Post Index procedure, on the day of the procedure immediately following treatment
Population: Target veins based measurement. Number of analyzed units corresponds to number of target veins with available data.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure. | 147 Target Veins |