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NCT01197833 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Boston Scientific Corporation.

Completed
Registry status
Phase 3
Development phase
117
Enrollment target

NCT01197833 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 117 participants.

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The verdict

NCT01197833, a Phase 3 study, has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
Phase 3
Development phase
117 participants
Enrollment target

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 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.

Interventions

  • DRUG endovenous ablation+polidocanol injectable microfoam 0.125%
  • DRUG Endovenous ablation+polidocanol injectable microfoam 1.0%
  • DRUG Endovenous ablation+polidocanol injectable foam 2.0%

Trial Details

FieldValue
Enrollment Target 117 participants
Start Date 2010-09
Est. Completion 2012-12
Phase Phase 3

Sponsor

Boston Scientific Corporation

280 total trials

What the Registry Record Tells You About NCT01197833

The ClinicalTrials.gov registry entry for NCT01197833 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which endovenous ablation+polidocanol injectable microfoam 0.125% is the first listed.

NCT01197833 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01197833 about?

NCT01197833 is a clinical study titled "Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities". 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...

What is the current status of trial NCT01197833?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 117 participants. The study started on 2010-09. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01197833?

The interventions under investigation include: endovenous ablation+polidocanol injectable microfoam 0.125% (DRUG), Endovenous ablation+polidocanol injectable microfoam 1.0% (DRUG), Endovenous ablation+polidocanol injectable foam 2.0% (DRUG).

Who is sponsoring clinical trial NCT01197833?

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

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.