A randomised controlled trial of GSV radiofrequency ablation devices
Research type
Research Study
Full title
A double blind randomised controlled trial of radiofrequency thermal ablation treatments of great saphenous varicose veins: Venefit (Closurefast), versus Radiofrequency Induced Thermal Therapy versus Endovenous Radiofrequency
IRAS ID
126245
Contact name
Isaac K Nyamekye
Contact email
Sponsor organisation
West Midlands South Comprehensive Local Research Network
Research summary
Varicose veins (VVs) affect upto 40% of the adult population, significantly impact on health-related quality of life and account for 1-2% of total healthcare spending. Complications of VVs include varicose eczema, leg swelling, pain, haemorrhage and ulceration.
Minimally invasive endovenous surgery has taken over from traditional surgical techniques as the treatment of choice due to avoidance of general anaesthesia, lower morbidity (pain and bruising), earlier return to work, lack of surgical wounds/scars and avoidance of nerve injury. Radiofrequency ablation (RFA) involves using a percutaneous catheter introduced under local anaesthetic to deliver radiofrequency energy to the inside of the vein causing it to heat up, permanently destroying it.
Venefit was the first RFA catheter to be designed for use under local anaesthetic. More recently the Radiofrequency induced Thermal Therapy (RFiTT) and EndoVenous Radiofrequency (EVRF) devices have come into clinical use. Each product has novel technology with theoretical advantages and limitations compared with the other. To date there has been no study which has directly compared the outcomes of these three RFA devices.
The aim of this study is to objectively assess outcomes of the three different RFA techniques. Eligible patients (not pregnant, aged 18-80 years, VVs which are not recurrent and amenable to RFA), will be invited to the study after consultation. Patients will be randomly allocated to one of the three treatments which will be carried out in a standardised manner except for the ablation which will be according to each manufacturer’s guidelines.
Patient follow-up will be at two weeks, 6 months, 2-years and 5-years and will include; objective assessment of failure of great saphenous vein closure with Duplex ultrasound, patient quality of life scores and post-operative pain scores and digital photographic assessment of extent of bruising. Clinicians carrying out these assessments of outcome will be blind to the RFA technique used.
REC name
London - Hampstead Research Ethics Committee
REC reference
14/LO/1232
Date of REC Opinion
9 Jul 2014
REC opinion
Favourable Opinion