NCT01197833

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

A Multicenter, Randomized, Blinded Study of Endovenous Thermal Ablation With or Without Varisolve™ Polidocanol Endovenous Microfoam (PEM) Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Great Saphenous Vein Incompetence
• Visible Varicosities

Interventions

Type	Name	Description
DRUG	endovenous ablation+polidocanol injectable microfoam 0.125%	All components except API
DRUG	Endovenous ablation+polidocanol injectable microfoam 1.0%	endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0%
DRUG	Endovenous ablation+polidocanol injectable foam 2.0%	Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-03-01
• Completion: 2012-12-01
• First posted: 2010-09-09
• Last updated: 2021-04-21
• Results posted: 2014-09-15

Locations

7 sites across 1 country: United States