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NCT01090739 · ClinicalTrials.gov registry record · NA
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
A NA study, sponsored by ASTORA Women's Health.
- Completed
- Registry status
- NA
- Development phase
- 207
- Enrollment target
NCT01090739: Completed NA study, sponsored by ASTORA Women's Health.
NCT01090739 is a NA study that has completed, run by ASTORA Women's Health. The registered enrollment target is 207 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01090739, a NA study, has completed, sponsored by ASTORA Women's Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 207 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
Primary Outcome
The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder.
Interventions
- DEVICE TOPAS Treatment for Fecal Incontinence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2010-04 |
| Est. Completion | 2016-04 |
| Phase | NA |
What the finished NCT01090739 record still lists
NCT01090739 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which TOPAS Treatment for Fecal Incontinence is the first listed.
NCT01090739 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01090739 about?
NCT01090739 is a clinical study titled "Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence". The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
What is the current status of trial NCT01090739?
This trial is currently completed. It is a NA study. The enrollment target is 207 participants. The study started on 2010-04. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01090739?
The interventions under investigation include: TOPAS Treatment for Fecal Incontinence (DEVICE).
Who is sponsoring clinical trial NCT01090739?
This trial is sponsored by ASTORA Women's Health, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01090739's enrollment target sits among peer trials
207 499th of 2000 higher than 1,502 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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