VNUS® ClosureFAST™ Ablation versus Laser for Varicose Veins

Completed

Conditions: Varicose veins
Circulatory System
Varicose veins of lower extremities

Registration Number: ISRCTN66818013

Lead Sponsor: Imperial College London (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 170

Inclusion Criteria

1. Adults aged over 18 years, either sex
2. Venous reflux of the great saphenous vein

Exclusion Criteria

1. Patients unfit for general anaesthesia
2. Current deep vein thrombosis
3. Previous venous surgery
4. Significant peripheral vascular disease/Ankle Brachial Blood Pressure Index (ABPI) less than 0.8

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average pain score at day 3 and day 10 following the procedure measured using an ungraduated visual analogue score (VAS) 0 = no pain, 10 = worst pain imaginable for 10 days following the procedure.

Secondary Outcome Measures

Name	Time	Method
1. Use of analgesia, measured at 10 days<br>2. Improvement in quality of life using the Aberdeen Varicose Vein Questionnaire (AVVQ), the 12-item Short Form (SF-12) and the Specific Quality of Life and Outcome Response - Venous (SQOR-V) questionnaires pre-operatively and at 6 weeks post-intervention<br>3. Abolition of reflux at 6 months measured using colour duplex<br>4. Improvements in venous refill times using digitial photoplethysmography, measured at 6 weeks and 6 months<br>5. Clinical improvement measured using the CEAP, Venous Clinical Severity Score (VCSS) and Venous Disability Score (VDS), measured at 6 weeks and 6 months<br>6. Return to normal activities and or work<br>7. Complications, assessed throughout the duration of the patient participation (6 months)