Does ablation of great saphenous vein treat deep vein incompetence v2
Research type
Research Study
Full title
Does radiofrequency ablation of the greater saphenous vein treat deep vein incompetence at common femoral vein level?
IRAS ID
262003
Contact name
Rahman Ahmed
Contact email
Sponsor organisation
King’s College Hospital R&I Governance Manager
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
Blood in the veins should travel towards the heart. If the veins are damaged, blood can flow in the wrong direction. This is known as reflux and may lead to visible, dilated varicose veins as blood pools in the legs. Occasionally, reflux occurs in the superficial and deep veins simultaneously, however in practice, reflux in the deep veins may not be reported or may be described as a secondary finding of reflux in the superficial veins.
To treat reflux in a superficial vein it can be heated and sealed from the inside to stop reversed flow. The study objective is to assess whether this treatment in a superficial vein (greater saphenous vein) successfully corrects reflux in the deep vein (common femoral vein). This will be achieved by ultrasound to identify whether reflux present in the deep vein before treatment of the superficial vein is still present after treatment, and whether it progresses into further deep veins. The findings will be important for current practice by assessing whether reporting of these scans is sufficient. Furthermore, more patients may be offered treatment if consultants can be sure that deep reflux will not persist or progress.
Eligible participants will be King’s College hospital patients (> 18 years) with prior deep vein reflux as well as superficial vein reflux and received treatment in 2016/17. There will be a single study visit per participant to Kings College vascular laboratory, lasting between 60-90 minutes where participants will give informed written consent, full patient history and demographic data; then have a physical examination and ultrasound scan. Duration of the study per participant will be up to 5 months from recruitment to study end. The total study duration will be 9 months from the recruitment of the first participant to the end of the final participant study visit.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
19/EE/0371
Date of REC Opinion
12 Dec 2019
REC opinion
Favourable Opinion