Status:
TERMINATED
A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence
Lead Sponsor:
Carbon Medical Technologies
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- History of fecal incontinence;
- Incontinence episodes over a 14-day period;
- Eighteen years of age or older;
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00762047
Start Date
June 1 2004
End Date
June 1 2009
Last Update
July 30 2013
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