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NCT01655498 · ClinicalTrials.gov registry record · NA

A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)

A NA study, sponsored by Pelvalon.

Completed
Registry status
NA
Development phase
61
Enrollment target

NCT01655498: Completed NA study, sponsored by Pelvalon.

NCT01655498 is a NA study that has completed, run by Pelvalon. The registered enrollment target is 61 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01655498, a NA study, has completed, sponsored by Pelvalon.

COMPLETED
Registry status
NA
Development phase
61 participants
Enrollment target

Study Summary

The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.

Primary Outcome

Subjects with at least a 50% reduction in FI episodes (major or minor soiling)

Interventions

  • DEVICE vaginal bowel control system (LivSure)

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2012-08
Est. Completion 2014-03
Phase NA
Pelvalon

3 total trials

What the finished NCT01655498 record still lists

NCT01655498 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which vaginal bowel control system (LivSure) is the first listed.

NCT01655498 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01655498 about?

NCT01655498 is a clinical study titled "A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)". The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.

What is the current status of trial NCT01655498?

This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2012-08. Estimated completion is 2014-03.

What interventions are being tested in trial NCT01655498?

The interventions under investigation include: vaginal bowel control system (LivSure) (DEVICE).

Who is sponsoring clinical trial NCT01655498?

This trial is sponsored by Pelvalon, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01655498's enrollment target sits among peer trials

61 1164th of 2000 higher than 837 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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Source: ClinicalTrials.gov NCT01655498, the US trial registry maintained by the National Library of Medicine. NCT01655498 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.