Chronic Venous Insufficiency, Varicose Veins, Venous Reflux
Conditions
Keywords
Endovenous Ablation
Brief summary
The aim of the study is to evaluate the efficacy of non-invasive echotherapy for the treatment of varicose veins, within local population, using the Sonovein® device. The quality of life scores at baseline, 2 weeks, 3 months, 6 months and 12 months will be assessed using the EQ-50D, AVVQ and CIVIQ scores. Patient satisfaction at these time points will also be assessed.
Detailed description
Sonovein® is a unique echotherapy solution, combining therapeutic ultrasound and ultrasound for monitoring. The high-intensity ultrasound beam is focused on the vein through a magnifying glass. As thermal energy is delivered, the thermocoagulation property of ultrasound energy affects the vein wall, causing shrinking and collapsing of the target vein. Thus creating a fibrotic seal and occluding the vessel. The treated vein is immediately closed after the procedure, and its diameter will continuously reduce over time, becoming a fibrotic chord. The treatment along the vein is steered automatically via a touch screen monitor. In-beam linear ultrasound probe allows visualisation of the vein in real-time and insures optimal accuracy. The study involves prospective data collection of 30 patients that will be undergoing HIFU as choice of treatment for their varicose veins / CVI. Questionnaires will be conducted at 5 timepoints - baseline before procedure, 2 weeks, 3 months, 6 months and 12 months. Subjects will be seen at outpatient clinic post-procedure. Besides questionnaires, physical examination and duplex ultrasound scan will be conducted at 2 weeks, 3 months, 6 months and 12 months to ensure occlusion of treated vein.
Interventions
OTHERQuestionnaires
Questionnaires to assess quality of life
Sponsors
Singapore General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age \>21 years, able to understand the requirements of the study and provide informed consent. 2. C2 - C5 varicose veins / CVI 3. Symptomatic primary GSV, SSV or AASV incompetence, with reflux \>0.5 seconds on colour duplex, including one or more of the following symptoms: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling. 4. Patients who has GSV, SSV or AASV diameters of 3mm to 12mm in the standing position.
Exclusion criteria
1. Current DVT or history of DVT 2. Recurrent varicose veins 3. Pregnant patients 4. Arterial disease (ABPI\<0.8) 5. Sepsis 6. Patients who are unwilling to participate 7. Inability or unwillingness to complete questionnaires 8. Adverse reaction to sclerosant or cyanoacrylate 9. GSV, SSV or AASV severely tortuous 10. Life expectancy \< 1 year 11. Active treatment for malignancy other than non-melanoma skin cancer 12. Current, regular use of systemic anticoagulation (e.g. warfarin, heparin) 13. Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success at time of procedure | Immediately post-op | Occlusion of treated vein post-procedure |
| Change in anatomy of treated vessel | 2 weeks, 3 months, 6 months, 12 months post-procedure | Anatomical success as measured at each time-point using ultrasound to ensure occlusion of treated vein. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) | 2 weeks, 3 months, 6 months, 12 months post-procedure | To measure health status of varicose veins patients based on symptoms and impact on daily activities. A total score ranging from 0 to 100 will be tabulated, with 100 being worst quality of life |
| Clinical Change using Venous Clinical Severity Score (VCSS) | 2 weeks, 3 months, 6 months, 12 months post-procedure | VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe). |
| Pain Score | First 10 days post-procedure | Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain) |
| Quality of life score using EQ-5D questionnaire | 2 weeks, 3 months, 6 months, 12 months post-procedure | EQ5D is used to assess quality of life based on Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety, rated at 5 levels: no problems, slight problems, moderate problems, severe problems, unable to perform activity. Inputs from this questionnaire is used to observe for changes in quality of life overtime. |
| Occlusion rates | 2 weeks, 3 months, 6 months, 12 months post-procedure | Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded |
| Patient satisfaction with treatment | 2 weeks, 3 months, 6 months, 12 months post-procedure | A short survey to assess patient satisfaction and if there is any observed improvement in terms of appearance and symptoms post-procedure. |
| Time taken to return to work and normal activities | 10 days post-operation | — |
| Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ) | 2 weeks, 3 months, 6 months, 12 months post-procedure | CIVIQ is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging for 0 to 100 - the higher the value, the poorer the quality of life. |
Countries
Singapore
Contacts
Primary ContactCharyl Yap
Outcome results
None listed