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VNUS® ClosureFAST™ Ablation versus Laser for Varicose Veins
ISRCTN ISRCTN66818013
DOI 10.1186/ISRCTN66818013
ClinicalTrials.gov identifier
EudraCT number
Public title VNUS® ClosureFAST™ Ablation versus Laser for Varicose Veins
Scientific title VNUS® ClosureFAST™ Ablation versus Laser for Varicose Veins (VALVV): a randomised clinical trial
Acronym VALVV
Serial number at source CRO1037
Study hypothesis Radiofrequency ablation using VNUS® ClosureFAST™ will result in significantly less post-operative pain and a greater improvement in quality of life in comparison to laser ablation.

As of 11/08/2009 this record has been updated to indicate that this trial has now closed to recruitment. The end of recruitment date was 30/06/2009. Follow-up will continue until 31/01/2010.
Lay summary
Ethics approval Charing Cross Research Ethics Committee gave approval on 6th May 2008 (ref: 08/H0711/19)
Study design Prospective randomised single-blind clinical trial, single centre
Countries of recruitment United Kingdom
Disease/condition/study domain Varicose veins
Participants - inclusion criteria 1. Adults aged over 18 years, either sex
2. Venous reflux of the great saphenous vein
Participants - 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
Anticipated start date 07/07/2008
Anticipated end date 31/01/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 170
Interventions 1. Endovenous radiofrequency ablation 6-month follow-up duration
2. Endovenous laser ablation 6-month follow-up duration
Primary outcome measure(s) 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 measure(s) 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)
Sources of funding Mason Medical Research Foundation (UK)
Trial website
Publications 1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20473992
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21129895
Contact name Prof  Alun  Davies
  Address 4 East Department of Vascular Surgery
Charing Cross Hospital
Fulham Palace Road
  City/town London
  Zip/Postcode W6 8RF
  Country United Kingdom
Sponsor Imperial College London (UK)
  Address c/o Gary Roper
Research Governance Manager of Imperial College
Clinical Reserach Governance Office, G02
Sir Alexander Fleming Building
Exhibition Road
  City/town London
  Zip/Postcode SW7 2AZ
  Country United Kingdom
  Sponsor website: http://www3.imperial.ac.uk/
Date applied 27/11/2008
Last edited 16/03/2011
Date ISRCTN assigned 03/12/2008
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