Comparing mechanochemical endovenous ablation using Flebogrif with endovenous laser ablation in the treatment of primary great saphenous vein incompetence: protocol for a multicentre, open-label, non-inferiority, observer-blinded, randomised controlled trial (REBORN trial)

Endovenous laser ablation (EVLA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. However, the use of thermal ablation requires tumescent anaesthesia and is associated with a risk of thermal damage. Mechanochemical endovenous ablation (MOCA) is a non-thermal ablation (NTA) alternative, which combines mechanical endothelial damage with the infusion of a sclerosant liquid or foam. Tumescent anaesthesia is not required. Preliminary experiences with MOCA using the Clarivein device show less intraprocedural and postprocedural pain and a faster clinical improvement compared with EVLA. Flebogrif (Balton, Poland) is a relatively new MOCA device. To determine the role of MOCA using Flebogrif, a well-designed, randomised controlled clinical trial of sufficient sample size and follow-up time is required. In this article, we provide the study protocol for the REBORN trial, aiming to demonstrate that MOCA using Flebogrif is not inferior to EVLA for the outcome of anatomical success in the treatment of GSV incompetence.