CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 235 enrolled
Drug / intervention
polidocanol injectable foam, 0.125% +3 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/NCT01231373
NCT01231373Phase 3Completed
CompareCT.gov

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"

Boston Scientific Corporation·interventional·Posted Nov 1, 2010·Updated Apr 21, 2021

In Brief

A Phase 3 clinical trial evaluating polidocanol injectable foam, 0.125%, polidocanol injectable foam, 0.5%, and 2 other interventions for Varicose Veins. Completed, enrolled 235 participants across 12 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaricose Veins
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 1, 2010
Enrollment StartNov 1, 2010
Primary CompletionSep 1, 2011
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.7 years ago

Interventions

polidocanol injectable foam, 0.125%drug

active placebo for blinding

polidocanol injectable foam, 0.5%drug

0.5% polidocanol foam injection

polidocanol injectable foam, 1.0%drug

1.0% polidocanol foam injection

Vehicledrug

injection of vehicle comparator