Comparing Mechanochemical Ablation and Ultrasound-Guided Foam Sclerotherapy for Treating Varicose Veins in the Great Saphenous Vein

What this Trial Is About

Researchers are evaluating two minimally invasive treatments for varicose veins in the legs, focusing on the great saphenous vein. The study compares ultrasound-guided foam sclerotherapy, which involves injecting a special foam to close the vein, with mechanochemical ablation using the Flebogrif4 catheter, which combines a device and medication to close the vein. The aim is to assess how well the treated vein stays closed, improvement in quality of life, pain during the procedure, and potential complications. The study will randomly assign 50 patients with varicose veins to one of two groups. One group receives foam sclerotherapy through ultrasound-guided injection, while the other undergoes mechanochemical ablation with the Flebogrif4 catheter under ultrasound guidance. Both treatments use local anesthesia and include treatment of small varicose veins with polidocanol foam. A tourniquet is applied during some procedures to prevent foam dispersion, and the site of vein puncture varies by the extent of insufficiency. Participants will be followed for one year, with clinical evaluations and ultrasound exams to monitor vein closure and disease severity. Quality of life will be assessed using questionnaires adapted for Brazilian patients. Researchers will measure pain during the procedure and track any complications. These evaluations will help compare the effectiveness and safety of the two treatments over time.

Mechanochemical Ablation Versus Ultrasound-Guided Foam Sclerotherapy of the Great Saphenous Vein