VNUS® ClosureFAST™ Ablation versus Laser for Varicose Veins

VNUS® ClosureFAST™ Ablation versus Laser for Varicose Veins (VALVV): a randomised clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66818013

Enrollment

170

Registered

2008-12-03

Start date

2008-07-07

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose veins Circulatory System Varicose veins of lower extremities

Interventions

1. Endovenous radiofrequency ablation 6-month follow-up duration 2. Endovenous laser ablation 6-month follow-up duration

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Use of analgesia, measured at 10 days 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 3. Abolition of reflux at 6 months measured using colour duplex 4. Improvements in venous refill times using digitial photoplethysmography, measured at 6 weeks and 6 months 5. Clinical improvement measured using the CEAP, Venous Clinical Severity Score (VCSS) and Venous Disability Score (VDS), measured at 6 weeks and 6 months 6. Return to normal activities and or work 7. Complications, assessed throughout the duration of the patient participation (6 months)	—

Measure

Time frame

1. Use of analgesia, measured at 10 days 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 3. Abolition of reflux at 6 months measured using colour duplex 4. Improvements in venous refill times using digitial photoplethysmography, measured at 6 weeks and 6 months 5. Clinical improvement measured using the CEAP, Venous Clinical Severity Score (VCSS) and Venous Disability Score (VDS), measured at 6 weeks and 6 months 6. Return to normal activities and or work 7. Complications, assessed throughout the duration of the patient participation (6 months)

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026