Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 90
- Primary Endpoint
- The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score
Study Overview
Brief Summary
The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women. This study has been designed to assess the safety, effectiveness and performance of Durasphere in adults suffering from fecal incontinence under monitored clinical conditions.
The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •History of fecal incontinence;
- •Incontinence episodes over a 14-day period;
- •Eighteen years of age or older;
Exclusion Criteria
- •Abnormalities of the external sphincter greater than 10 mm;
- •Fibrosis of the tissue at the likely injection sites;
- •Has a condition that could lead to significant postoperative complications
- •Rectal varices;
- •Cancer of the rectum or colon, undergoing active treatment;
- •Crohn's disease or ulcerative colitis;
- •Chronic diarrhea unmanageable by drugs and/or diet;
- •Rectal bleeding;
- •Pregnant or within one year postpartum.
Outcomes
Primary Outcomes
The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score
Time Frame: 6 month
Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere.
Time Frame: Throughout study
The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score
Time Frame: 12 month
Secondary Outcomes
No secondary outcomes reported