LIBERATE - PRO: Eclipse™ System Registry

Completed

Conditions studied: Fecal Incontinence, Bowel Dysfunction, Bowel Incontinence, Accidental Bowel Leakage

In brief

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.

Key facts

Study ID

NCT03028636

Run by

Pelvalon, Inc.

People needed

17

Starts

2016-09-19

Expected to finish

2019-02-27

Last updated by the study team

2020-01-28

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• There are no specific exclusions as this is a data collection registry on a commercially approved product

Where it is running

• Pelvalon, Inc. — Sunnyvale, California, United States

Full record on ClinicalTrials.gov

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