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NCT02428595 · ClinicalTrials.gov registry record · NA
A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
A NA study of Fecal Incontinence, sponsored by Pelvalon.
- Completed
- Registry status
- NA
- Development phase
- 137
- Enrollment target
- 11
- Study locations
NCT02428595: Completed NA study of Fecal Incontinence, sponsored by Pelvalon.
NCT02428595 is a NA study of Fecal Incontinence that has completed, run by Pelvalon. The registered enrollment target is 137 participants, below the 329-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (58% lower). The trial reports 11 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02428595, a NA study of Fecal Incontinence, has completed, sponsored by Pelvalon.
- COMPLETED
- Registry status
- NA
- Development phase
- 137 participants
- Enrollment target
- 11
- Study locations
Study Summary
Multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use.
Primary Outcome
Count of patients with \>50% reduction in the average number of FI episodes per week as compared to baseline.
Conditions Studied
Interventions
- DEVICE Eclipse™ System
Study Locations (11)
Alabama
- University of Alabama - Birmingham
Massachusetts
- Massachusetts General Hospital (MGH) - Boston
New Mexico
- University of New Mexico - Albuquerque
North Carolina
- University of North Carolina - Raleigh
Ohio
- Christ Hospital - Cincinnati
Oklahoma
- University of Oklahoma - Oklahoma City
Pennsylvania
- University of Pennsylvania - Philadelphia
Rhode Island
- Brown University (WIHRI) - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2015-05-15 |
| Est. Completion | 2018-07-18 |
| Phase | NA |
What the finished NCT02428595 record still lists
NCT02428595 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 329-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Fecal Incontinence appearing as the primary indexed condition, and to 1 intervention - of which Eclipse™ System is the first listed.
NCT02428595 lists 11 locations in 11 states (Alabama, Massachusetts, New Mexico).
Frequently Asked Questions
What is clinical trial NCT02428595 about?
NCT02428595 is a clinical study titled "A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women". Multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use.
What is the current status of trial NCT02428595?
This trial is currently completed. It is a NA study. The enrollment target is 137 participants. The study started on 2015-05-15. Estimated completion is 2018-07-18.
What conditions does trial NCT02428595 study?
This clinical trial studies the following conditions: Fecal Incontinence.
What interventions are being tested in trial NCT02428595?
The interventions under investigation include: Eclipse™ System (DEVICE).
Who is sponsoring clinical trial NCT02428595?
This trial is sponsored by Pelvalon, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02428595 being conducted?
This trial has 11 study locations across Alabama, Massachusetts, New Mexico, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fecal Incontinence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02428595's enrollment target sits among peer trials
137 9th of 22 higher than 14 of 22 other Fecal Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fecal Incontinence 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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