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

NACompletedINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

May 15, 2015

Primary Completion Date

July 18, 2018

Study Completion Date

July 18, 2018

Conditions
Fecal Incontinence
Interventions
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."

Trial Locations (11)

19104

University of Pennsylvania, Philadelphia

27607

University of North Carolina, Raleigh

35233

University of Alabama, Birmingham

45219

Christ Hospital, Cincinnati

53792

University of Wisconsin, Madison

73104

University of Oklahoma, Oklahoma City

77030

Houston Methodist, Houston

87131

University of New Mexico, Albuquerque

99204

Providence Sacred Heart, Spokane

02114

Massachusetts General Hospital (MGH), Boston

02903

Brown University (WIHRI), Providence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pelvalon, Inc.

INDUSTRY