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A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage


A Multi-Center, Prospective, Non-Randomized Study of the Renew Insert Efficacy, Safety and Tolerability For the Management of Accidental Bowel Leakage Due to Bowel Incontinence




The purpose of this study is to determine whether the use of the Renew Insert is effective, tolerable and safe in the treatment of accidental bowel leakage due to bowel incontinence.

Study Status: Completed


Condition Intervention Phase
Bowel Incontinence Device: Renew Insert N/A

Verified by Renew Medical September, 2013

Sponsored by: Renew Medical
Information provided by: Renew Medical identifier: NCT01475474

Study Type: Interventional

Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Florida
Weston, Florida 33331
United States

Steven D Wexner, MD., Principal Investigator
Emily Lukacz, MD., Principal Investigator
Mark Segall, MD., Principal Investigator
Eric G Weiss, MD., Principal Investigator

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