Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities

Summary

Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) when used following an approved heat treatment in subjects with varicose veins.

Timeline

Start

2010-09

Primary completion

2012-03

Completion

2012-12

Publications

• Vasquez M, Gasparis AP; Varithena(R) 017 Investigator Group. A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities. Phlebology. 2017 May;32(4):272-281. doi: 10.1177/0268355516637300. Epub 2016 Mar 7.

Drugs

Indications