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NCT03028636 · ClinicalTrials.gov registry record
LIBERATE - PRO: Eclipse™ System Registry
A clinical trial, sponsored by Pelvalon.
- Completed
- Registry status
- 17
- Enrollment target
NCT03028636: Completed study, sponsored by Pelvalon.
NCT03028636 is a clinical trial that has completed, run by Pelvalon. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03028636 has completed, sponsored by Pelvalon.
- COMPLETED
- Registry status
- 17 participants
- Enrollment target
Study Summary
A prospective, open label post market registry to collect Patient Reported Outcomes in an online data capture registry, maintained by Pelvalon, of women with fecal incontinence exiting the LIBERATE study (NCT02428595) continuing to use the Eclipse System for bowel control.
Primary Outcome
The score is based on 7 questions and is a measure of severity of fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in frequency of FI episodes and subjects' perceptions of relief. The score reflects the severity of FI and ranges from 0 (complete continence, better outcome) to 24 (complete incontinence, worse outcome). A reduction in the St. Mark's score is a better outcome. The mean change from baseline score (prior to treatment) will be calculated and reporte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2016-09-19 |
| Est. Completion | 2019-02-27 |
What the finished NCT03028636 record still lists
NCT03028636 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03028636 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03028636 about?
NCT03028636 is a clinical study titled "LIBERATE - PRO: Eclipse™ System Registry". A prospective, open label post market registry to collect Patient Reported Outcomes in an online data capture registry, maintained by Pelvalon, of women with fecal incontinence exiting the LIBERATE study (NCT02428595) continuing to use the Eclipse System for bowel control.
What is the current status of trial NCT03028636?
This trial is currently completed. The enrollment target is 17 participants. The study started on 2016-09-19. Estimated completion is 2019-02-27.
Who is sponsoring clinical trial NCT03028636?
This trial is sponsored by Pelvalon, which has 3 total clinical trials registered on ClinicalTrials.gov.
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