NCT02428595

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Pelvalon, Inc. · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	Eclipse™ System	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.

Timeline

• Start date: 2015-05-15
• Primary completion: 2018-07-18
• Completion: 2018-07-18
• First posted: 2015-04-29
• Last updated: 2019-09-24
• Results posted: 2019-09-24

Locations

11 sites across 1 country: United States