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A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence


A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence




The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase.

Study Status: Active, not recruiting


Condition Intervention Phase
Fecal Incontinence Device: NASHA/Dx Injectable Gel
Device: Sham Injection

Verified by Q-Med Scandinavia, Inc. July, 2011

Sponsored by: Q-Med Scandinavia, Inc.
Information provided by: Q-Med Scandinavia, Inc. identifier: NCT00605826

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States


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