Varicose Veins
Conditions
Brief summary
The purpose of this study is to evaluate pain the patient experienced following treatment of varicose veins with Varithena® compared to radiofrequency ablation.
Detailed description
A study that evaluates pain following treatment of varicose veins in patients treated with Varithena® and those treated with RFA.
Interventions
DRUGVarithena®
Varithena® treatment in accordance with full prescribing information and instructions for use
DEVICERadiofrequency ablation
Radiofrequency ablation conducted per physicians' standard of care.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women; age 18 to 75 years 2. Bilateral incompetence of SFJ (reflux \>1 second on duplex ultrasonography) associated with incompetence of the GSV in both legs 3. GSV diameter \>5 mm measured from the superficial epigastric vein to 10 cm below the SFJ while in a standing position in both legs 4. Eligible to receive RFA treatment and Varithena® treatment 5. CEAP C2-C5 (inclusive) 6. Patient is participating in usual work and home activities with no changes anticipated for the duration of the study 7. Ability to comprehend and sign an informed consent and complete study questionnaires written in English 8. Ability to reliably use an electronic diary to record pain and analgesic/opioid use in accordance with the protocol
Exclusion criteria
1. Prior GSV treatment in either leg 2. Non-venous source of pain in either leg that could confound the results of the study 3. Use of chronic analgesic or opiate medications or medical history that could result in the regular use of pain medications during the study 4. History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior or active DVT on duplex ultrasound 5. Deep venous reflux unless clinically insignificant in comparison to superficial reflux 6. Inability to wear post-procedure compression bandaging and stockings 7. Reduced mobility (unable to walk unaided for 5 minutes per waking hour) 8. Major surgery, prolonged hospitalization or pregnancy within 3 months of screening 9. Major co-existing disease (e.g., malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.) 10. Contraindications to Varithena® (e.g., acute thromboembolic disease) or RFA according to the manufacturer's prescribing information 1. Varithena® contraindication due to known allergy to polidocanol 2. RFA contraindication due to veins being too large 3. RFA Contraindication due to veins being too tortuous 11. Known allergic response to polidocanol and/or multiple allergic reactions 12. Current or history of alcohol or drug abuse 13. Pregnant or lactating women 14. Women of childbearing potential not using effective contraception for at least one month prior to study treatment and/or unwilling to continue birth control for the duration of the study 15. Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 14 day average (0-100) | 14-day average post-treatment pain using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Pain | immediately following procedure | degree of procedural pain perceived by the patient obtained immediately following the procedure using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine |
| Patient Preference | 8 weeks | Patient preference for RFA or Varithena® using e-diary |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varithena® Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use followed by Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care.
Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care followed by Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Part 2 | Protocol Violation | 0 | 1 |
| Part 2 | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Varithena® |
|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 11.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 4 / 34 | 3 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
Pain
14-day average post-treatment pain using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine.
Time frame: 14 day average (0-100)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varithena® | Pain | 11.3 units on a scale | Standard Error 2.9 |
| Radiofrequency Ablation | Pain | 9.5 units on a scale | Standard Error 2.9 |
Secondary
Patient Preference
Patient preference for RFA or Varithena® using e-diary
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Varithena® | Patient Preference | 19 Participants |
| Radiofrequency Ablation | Patient Preference | 14 Participants |
Secondary
Procedural Pain
degree of procedural pain perceived by the patient obtained immediately following the procedure using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine
Time frame: immediately following procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varithena® | Procedural Pain | 16.4 units on a scale | Standard Error 3.53 |
| Radiofrequency Ablation | Procedural Pain | 17.8 units on a scale | Standard Error 3.53 |