3 RF Trial Long Term Study
Research type
Research Study
Full title
Long term outcomes of the double blind randomised controlled trial of radiofrequency thermal ablation treatments of great saphenous varicose veins: Venefit (Closurefast), vs. Radiofrequency induced Thermal Therapy vs. Endovenous Radiofrequency
IRAS ID
288300
Contact name
Isaac Nyamekye
Contact email
Sponsor organisation
Worcestershire Acute Hospitals NHS Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Not applicable, Not applicable
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
The original 3RF Trial demonstrated a clear technical difference between three established radiofrequency thermal ablation devices that are used for varicose vein treatments namely with endovenous radiofrequency (EVRF), Venefit and radiofrequency induced thermal therapy (RFITT). We showed that EVRF had significantly greater early technical failures at 6 month compared to Venefit and RFIT. This has already influenced clinical practice.
However there were no clinical differences detected between the devices up to 12 months.
Venous papers are often criticised for having too short a follow-up period and at least 5 year follow-up is recommended to detect clinical differences.
The 3RF long term study aims to address this criticism. This study aims to assess the durability of the clinical improvement that was achieved for all three devices in the original study. We will also assess the rates of attrition of the ablations procedures over this time.REC name
London - Bloomsbury Research Ethics Committee
REC reference
20/LO/1293
Date of REC Opinion
15 Jan 2021
REC opinion
Further Information Favourable Opinion