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A Prospective, Multi-Center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence


Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence




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 Status: Active, not recruiting


Condition Intervention Phase
Fecal Incontinence Device: Durasphere FI
Device: Sham
Phase 2

Verified by Carbon Medical Technologies September, 2008

Sponsored by: Carbon Medical Technologies
Information provided by: Carbon Medical Technologies identifier: NCT00762047

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Cleveland Clinic Florida-Weston
Weston, Florida 33331
United States

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States


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