CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 117 enrolled
Drug / intervention
endovenous ablation+polidocanol injectable microfoam 0.125% +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01197833
NCT01197833Phase 3Completed
CompareCT.gov

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

Boston Scientific Corporation·interventional·Posted Sep 9, 2010·Updated Apr 21, 2021

In Brief

A Phase 3 clinical trial evaluating endovenous ablation+polidocanol injectable microfoam 0.125%, Endovenous ablation+polidocanol injectable microfoam 1.0%, and 1 other intervention for Great Saphenous Vein Incompetence and Visible Varicosities. Completed, enrolled 117 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGreat Saphenous Vein Incompetence, Visible Varicosities
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2010
Enrollment StartSep 1, 2010
Primary CompletionMar 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.8 years ago

Interventions

endovenous ablation+polidocanol injectable microfoam 0.125%drug

All components except API

Endovenous ablation+polidocanol injectable microfoam 1.0%drug

endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0%

Endovenous ablation+polidocanol injectable foam 2.0%drug

Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%