VNUS® ClosureFAST™ Ablation versus Laser for Varicose Veins

ISRCTN	ISRCTN66818013
DOI	https://doi.org/10.1186/ISRCTN66818013
Protocol serial number	CRO1037
Sponsor	Imperial College London (UK)
Funder	Mason Medical Research Foundation (UK)

Submission date: 27/11/2008
Registration date: 03/12/2008
Last edited: 16/03/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Alun Davies
Scientific

4 East Department of Vascular Surgery
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective randomised single-blind clinical trial, single centre
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	VNUS® ClosureFAST™ Ablation versus Laser for Varicose Veins (VALVV): a randomised clinical trial
Study acronym	VALVV
Study objectives	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(s)	Charing Cross Research Ethics Committee gave approval on 6th May 2008 (ref: 08/H0711/19)
Health condition(s) or problem(s) studied	Varicose veins
Intervention	1. Endovenous radiofrequency ablation 6-month follow-up duration 2. Endovenous laser ablation 6-month follow-up duration
Intervention type	Other
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.
Key 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)
Completion date	31/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	170
Key inclusion criteria	1. Adults aged over 18 years, either sex 2. Venous reflux of the great saphenous vein
Key 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
Date of first enrolment	07/07/2008
Date of final enrolment	31/01/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

4 East Department of Vascular Surgery

London
W6 8RF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2010		Yes	No
Results article	results	01/02/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes