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

NCT01197833 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

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 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

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%

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
2010-09-30
Primary Completion
2012-03-31
Completion
2012-12-31

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 NCT01197833 on ClinicalTrials.gov