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

Pelvalon

Status

Completed

Conditions

Fecal Incontinence

Treatments

Device: Eclipse™ System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02428595

CA005

Details and patient eligibility

About

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.

Enrollment

137 patients

Sex

Female

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Abbreviated Inclusion Criteria:

History of Fecal Incontinence (FI) for at least 6 months
Subject willing and able to give written informed consent to participate in the study
Subject can read, write and communicate fluently in English
Subject willing and able to comply with visit schedule
Subject is able to physically manage the insertion and removal of the Insert

Abbreviated Exclusion Criteria:

Vaginal childbirth within the last 18 months
Currently pregnant or planning pregnancy during the study period
Acute infections or genito-urinary injuries that would impact comfortable device use
Current treatment for Fecal Incontinence other than medical management
Removal or diversion of any portion of the bowel
Recent urogenital or colorectal surgeries
Chronic abdominal pain in absence of diarrhea
Chronic (>6 mos) rectal, anal or pelvic pain
Chronic watery diarrhea, unmanageable by drugs or diet
Inflammatory Bowel Disease (IBD) such as Chron's or Ulcerative Colitis
Rectal prolapse (mucosal or full thickness)
Grade III or IV hemorrhoids
Pelvic organ prolapse beyond the plane of the hymen
Concurrent use of intra-vaginal pessary or other device
Anal or pelvic malignancy within last 5 years
History of pelvic irradiation for cancer
Other significant medical or lifestyle factors that could confound the interpretation of the primary endpoint or increase subject risk