N/A
Completed N=17
LIBERATE - PRO: Eclipse™ System Registry
Fecal Incontinence · Bowel Dysfunction · Bowel Incontinence · Accidental Bowel Leakage
Source: ClinicalTrials.gov NCT03028636 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score — -6.58; -5.47; -7.57; -4.64 Score on a Scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score |
-6.58; -5.47; -7.57; -4.64 | — |
| SECONDARY Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score |
6; 6; 7; 5; 3; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has completed the 12-month visit in the LIBERATE study (NCT02428595)
- Subject has elected to continue to use the Eclipse System outside of the LIBERATE study
- Subject provides electronic informed consent and HIPAA authorization
Exclusion Criteria
There are no specific exclusions as this is a data collection registry on a commercially approved product
Data sourced from ClinicalTrials.gov (NCT03028636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.