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

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

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.

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