Liberate

A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women

Liberate [NCT02428595]

The Eclipse System is a vaginal bowel control (VBC) therapy intended to provide bowel control for women with fecal incontinence. It is comprised of a non-surgical device placed in the vagina (referred to as the "Eclipse Insert") and a pressure-regulated pump which is used to inflate and deflate the Insert. A Sizing Kit, for use during the fitting process, and an evaluation Insert (referred to as the Trial Insert) are also part of the Eclipse System.
Other Name: Vaginal Bowel Control (VBC) Therapy

Device: Eclipse System

Primary Investigator: Paquette

Drug/Device Information
Evaluate the safety of the Eclipse System for fecal incontinence in women
Vaginal bowel control therapy utilizing a non-surgical device placed in the vagina (referred to as the "Eclipse Insert") and a pressure-regulated pump which is used to inflate and deflate the insert
Nonrandomized
Pelvalon, Inc.