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Clinical Study to Investigate the Effectiveness of the TOPAS Sling System to Treat Fecal Incontinence


An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)




The purpose of this study is to demonstrate that the TOPAS Sling System effectively treats fecal incontinence as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.

Study Status: Active, not recruiting


Condition Intervention Phase
Fecal Incontinence Device: TOPAS Sling System N/A

Verified by American Medical Systems December, 2012

Sponsored by: American Medical Systems
Information provided by: American Medical Systems identifier: NCT01090739

Study Type: Interventional

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

Cleveland Clinic Foundation - Florida
Weston, Florida 33331
United States

Cleveland Clinic Foundation - Ohio
Cleveland, Ohio 44195
United States

Anders Mellgren, MD., Principal Investigator
Dee Fenner, MD., Principal Investigator

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