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NCT01231373 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Varicose Veins, sponsored by Boston Scientific Corporation.

Completed
Registry status
Phase 3
Development phase
235
Enrollment target
12
Study locations

NCT01231373 is a Phase 3 study of Varicose Veins that has completed, run by Boston Scientific Corporation. The registered enrollment target is 235 participants, above the 131-participant average among 6 other Varicose Veins trials with a reported enrollment target (79% higher). The trial reports 12 study locations across 9 states.

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The verdict

NCT01231373, a Phase 3 study of Varicose Veins, has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
Phase 3
Development phase
235 participants
Enrollment target
12
Study locations

Study 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 Studied

Varicose Veins

Interventions

  • DRUG Vehicle
  • DRUG polidocanol injectable foam, 0.125%
  • DRUG polidocanol injectable foam, 0.5%
  • DRUG polidocanol injectable foam, 1.0%

Study Locations (12)

California

  • - San Diego
  • - San Diego

Maryland

  • - Frederick
  • - Hunt Valley

Pennsylvania

  • - Monroeville
  • - Pittsburgh

Alabama

  • - Dothan

Indiana

  • - Lafayette

New Mexico

  • - Los Alamos

Oklahoma

  • - Oklahoma City

South Carolina

  • - Greenville

Trial Details

FieldValue
Enrollment Target 235 participants
Start Date 2010-11
Est. Completion 2014-08
Phase Phase 3

Sponsor

Boston Scientific Corporation

280 total trials

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What the Registry Record Tells You About NCT01231373

The ClinicalTrials.gov registry entry for NCT01231373 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 131-participant average among 6 other Varicose Veins trials with a reported enrollment target (79% higher). The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Varicose Veins appearing as the primary indexed condition, and to 4 interventions - of which Vehicle is the first listed.

NCT01231373 reports 12 study locations spanning 9 distinct geographic areas - top geographies include California, Maryland, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01231373 about?

NCT01231373 is a clinical study titled "Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence". 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 concentra...

What is the current status of trial NCT01231373?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2010-11. Estimated completion is 2014-08.

What conditions does trial NCT01231373 study?

This clinical trial studies the following conditions: Varicose Veins.

What interventions are being tested in trial NCT01231373?

The interventions under investigation include: Vehicle (DRUG), polidocanol injectable foam, 0.125% (DRUG), polidocanol injectable foam, 0.5% (DRUG), polidocanol injectable foam, 1.0% (DRUG).

Who is sponsoring clinical trial NCT01231373?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01231373 being conducted?

This trial has 12 study locations across Alabama, California, Indiana, Maryland, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.