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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01197833

Public ClinicalTrials.gov record NCT01197833. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 2:27 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01197833
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boston Scientific Corporation
Industry
Enrollment
117 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2010 (Type not available)
Primary completion
Mar 2012 (Actual)
Completion
Dec 2012 (Actual)
Last update posted
Apr 21, 2021

2010 – 2012

United States locations

U.S. sites
7
U.S. states
6
U.S. cities
7
Facility City State ZIP Site status
Not listed Scottsdale Arizona 85255 —
Not listed Bradenton Florida 34209 —
Not listed Oak Brook Illinois 60523 —
Not listed North Tonawanda New York 14120 —
Not listed Stony Brook New York 11974 —
Not listed Charlotte North Carolina 28207 —
Not listed Kirkland Washington 98034 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01197833, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 21, 2021 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01197833 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →