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

Summary

This study compares two minimally invasive treatments for varicose veins in the legs, specifically the great saphenous vein. Varicose veins can cause symptoms such as leg pain, swelling, and skin changes. One commonly used treatment is foam sclerotherapy, where a special foam is injected into the vein to close it. This method is simple and allows patients to return quickly to their daily activities, but sometimes the vein can reopen, requiring additional treatments. Another option is mechanochemical ablation, which combines a small device with a medication to close the vein. This method also allows for quick recovery and may have a lower chance of the vein reopening. In this study, 50 patients with varicose veins will be randomly assigned to receive one of these two treatments. Doctors will follow patients over time to evaluate: How well the treated vein stays closed Improvement in quality of life Pain during the procedure Possible complications All procedures are performed with local anesthesia, and additional small varicose veins are treated at the same time.

Timeline

Start

2026-05

Primary completion

2027-08

Completion

2027-11

Publications

• Background Epstein D, Onida S, Bootun R, Ortega-Ortega M, Davies AH. Cost-Effectiveness of Current and Emerging Treatments of Varicose Veins. Value Health. 2018 Aug;21(8):911-920. doi: 10.1016/j.jval.2018.01.012. Epub 2018 Mar 15.
• Background Petrone A, Peluso A, Ammollo RP, Turchino D, Del Guercio L, Andreucci M, Serra R, Bracale UM. Selective crossectomy combined with mechanochemical ablation in the treatment of great saphenous vein insufficiency: Early results of a single center experience. Phlebology. 2022 Aug;37(7):522-528. doi: 10.1177/02683555221092194. Epub 2022 Apr 25.
• Background Whing J, Nandhra S, Nesbitt C, Stansby G. Interventions for great saphenous vein incompetence. Cochrane Database Syst Rev. 2021 Aug 11;8(8):CD005624. doi: 10.1002/14651858.CD005624.pub4.
• Background Nicolaides AN, Allegra C, Bergan J, Bradbury A, Cairols M, Carpentier P, Comerota A, Delis C, Eklof B, Fassiadis N, Georgiou N, Geroulakos G, Hoffmann U, Jantet G, Jawien A, Kakkos S, Kalodiki E, Labropoulos N, Neglen P, Pappas P, Partsch H, Perrin M, Rabe E, Ramelet AA, Vayssaira M, Ioannidou E, Taft A. Management of chronic venous disorders of the lower limbs: guidelines according to scientific evidence. Int Angiol. 2008 Feb;27(1):1-59. No abstract available.

Drugs

Indications