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NCT00565136 · ClinicalTrials.gov registry record · Phase 1

Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms

A Phase 1 study of Fecal Incontinence, sponsored by ASTORA Women's Health.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target
5
Study locations

NCT00565136 is a Phase 1 study of Fecal Incontinence that has completed, run by ASTORA Women's Health. The registered enrollment target is 29 participants, below the 334-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (91% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT00565136, a Phase 1 study of Fecal Incontinence, has completed, sponsored by ASTORA Women's Health.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target
5
Study locations

Study Summary

The study purpose is to gain experience with the TOPAS system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence

Conditions Studied

Fecal Incontinence

Interventions

  • DEVICE TOPAS

Study Locations (5)

Massachusetts

  • Mount Auburn Hospital - Cambridge

Minnesota

  • University of Minnesota - Minneapolis

Ohio

  • The Christ Hospital - Cincinnati

Pennsylvania

  • St. Lukes Hospital - Allentown

Washington

  • Sacred Heart Hospital - Spokane

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2007-09
Est. Completion 2012-12
Phase Phase 1

Sponsor

ASTORA Women's Health

7 total trials

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What the Registry Record Tells You About NCT00565136

The ClinicalTrials.gov registry entry for NCT00565136 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 334-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (91% lower). The listed sponsor is ASTORA Women's Health, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Fecal Incontinence appearing as the primary indexed condition, and to 1 intervention - of which TOPAS is the first listed.

NCT00565136 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Massachusetts, Minnesota, Ohio.

Frequently Asked Questions

What is clinical trial NCT00565136 about?

NCT00565136 is a clinical study titled "Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms". The study purpose is to gain experience with the TOPAS system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence

What is the current status of trial NCT00565136?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2007-09. Estimated completion is 2012-12.

What conditions does trial NCT00565136 study?

This clinical trial studies the following conditions: Fecal Incontinence.

What interventions are being tested in trial NCT00565136?

The interventions under investigation include: TOPAS (DEVICE).

Who is sponsoring clinical trial NCT00565136?

This trial is sponsored by ASTORA Women's Health, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00565136 being conducted?

This trial has 5 study locations across Massachusetts, Minnesota, Ohio, Pennsylvania, Washington. 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.