Varicose veins, venous disease Circulatory System Varicose veins of other sites
Conditions
Interventions
Treatment arm one is:
VNUS ClosureFast radiofrequency ablation of the incompetent long or short saphenous vein with phlebectomies as per standard published treatment technique.
Treatment arm two is:
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults over 18 years of age 2. Symptomatic long or short saphenous vein reflux < 0.5 seconds on colour duplex
Exclusion criteria
Exclusion criteria: 1. Current DVT 2. Recurrent varicose veins 3. Arterial disease (ABPI <0.8) 4. Veins less than 3 mm in diameter 5. Hypercoagulability 6. Patients who are unwilling to participate 7. Inability or unwillingness to complete questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. A comparison of pain during the procedure measured using a patient-reported visual analogue score (VAS) comparing RFA and ClariVein® 2. Treatments will be performed under local anaesthetic with concomitant phlebectomy to treat varicosities 3. Pain during the procedure will be measured using a validated patient-reported Visual Analogue Score (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life at 30 days and 6 months measured using the Aberdeen Varicose Vein Severity Score (AVVSS) 2. Occlusion rates at 30 day and 6 months 3. Clinical success, including residual varicosities, complications and recurrence rates at 6 months 4. Improvements in generic quality of life using the EQ-5D at 30 days and 6 months 5. Clinical improvements measured using the Venous Clinical Severity Score (VCSS) at 30 days and 6 months 6. Time to return to work and normal activities assessed using a 30-day patient diary 7. A comparison of the cost-effectiveness of the treatment regimes will be made | — |
Countries
United Kingdom
Outcome results
None listed