Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CRO1037
Study information
Scientific title
VNUS® ClosureFAST™ Ablation versus Laser for Varicose Veins (VALVV): a randomised clinical trial
Acronym
VALVV
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Varicose veins
Intervention
1. Endovenous radiofrequency ablation 6-month follow-up duration
2. Endovenous laser ablation 6-month follow-up duration
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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
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)
Overall trial start date
07/07/2008
Overall trial end date
31/01/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adults aged over 18 years, either sex
2. Venous reflux of the great saphenous vein
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
170
Participant 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
Recruitment start date
07/07/2008
Recruitment end date
31/01/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
4 East Department of Vascular Surgery
London
W6 8RF
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
c/o Gary Roper
Research Governance Manager of Imperial College
Clinical Reserach Governance Office
G02
Sir Alexander Fleming Building
Exhibition Road
London
SW7 2AZ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Mason Medical Research Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20473992
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21129895
Publication citations
-
Results
Shepherd AC, Gohel MS, Brown LC, Metcalfe MJ, Hamish M, Davies AH, Randomized clinical trial of VNUS ClosureFAST radiofrequency ablation versus laser for varicose veins., Br J Surg, 2010, 97, 6, 810-818, doi: 10.1002/bjs.7091.
-
Results
Shepherd AC, Gohel MS, Lim CS, Davies AH, A study to compare disease-specific quality of life with clinical anatomical and hemodynamic assessments in patients with varicose veins., J. Vasc. Surg., 2011, 53, 2, 374-382, doi: 10.1016/j.jvs.2010.09.022.