Clinical Trial: A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence
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.
Detailed Summary:
Sponsor: Carbon Medical Technologies
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Carbon Medical Technologies
Dates:
Date Received: September 29, 2008
Date Started: June 2004
Date Completion:
Last Updated: July 29, 2013
Last Verified: January 2012
