NCT01231373

Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Varisolve Polidocanol Endovenous Microfoam (PEM) 0.5% and 1% Compared to Vehicle for the Treatment on Saphenofemoral Junction (SFJ) Incompetence "VANISH-2"

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 235 (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 three different concentrations of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Conditions

• Varicose Veins

Interventions

Type	Name	Description
DRUG	polidocanol injectable foam, 0.125%	active placebo for blinding
DRUG	polidocanol injectable foam, 0.5%	0.5% polidocanol foam injection
DRUG	polidocanol injectable foam, 1.0%	1.0% polidocanol foam injection
DRUG	Vehicle	injection of vehicle comparator

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-09-01
• Completion: 2014-08-01
• First posted: 2010-11-01
• Last updated: 2021-04-21
• Results posted: 2014-04-02

Locations

12 sites across 1 country: United States