CompletedNot Applicable

LIBERATE - PRO: Eclipse™ System Registry

United States17 participantsStarted 2016-09-19

Plain-language 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.

Who can participate

Age range19 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score

Timeframe: 3, 6, 9, and 12 months

Trial details

NCT IDNCT03028636

SponsorPelvalon, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-02-27

Results submitted2020-01-16

View on ClinicalTrials.gov More Fecal Incontinence trials