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

NCT01231373 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2021-04-21

Study results available
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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

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-09-30
Completion
2014-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01231373 on ClinicalTrials.gov