Gastrointestinal
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An Investigation of the TReatment of FecAL IncontiNence using the TOPAS Sling System FOR WoMen (TRANSFORM)
Primary Investigator:
Dr. M. Shane McNevin
Dr. M. Shane McNevin
Description:
The TRANSFORM study is being conducted to determine the effectiveness of an investigational device in reducing episodes of fecal incontinence. This study uses the TOPASTM Sling System which is an investigational device from American Medical Systems (AMS). The TOPASTM Sling System is a small piece of mesh placed behind the anus through small incisions during a minimally invasive surgical procedure. The mesh creates a sling to give extra support to muscle that has been damaged or weakened
The TRANSFORM study is being conducted to determine the effectiveness of an investigational device in reducing episodes of fecal incontinence. This study uses the TOPASTM Sling System which is an investigational device from American Medical Systems (AMS). The TOPASTM Sling System is a small piece of mesh placed behind the anus through small incisions during a minimally invasive surgical procedure. The mesh creates a sling to give extra support to muscle that has been damaged or weakened
Eligibility:
Individuals aged 18 or older with a documented history of Fecal Incontinence (FI) for at least 6 months.
Other eligibility criteria may apply. Please see study coordinator.
Exclusions:
History of significant obstructive defecation
Current rectal or vaginal prolapse
Inflammatory bowel disease, chronic diarrhea, rectal or colon cancer within 2 years, history of pelvic radiation.
Other exclusion criteria may apply. Please see study coordinator.
Study Timeline:
Currently enrolling
Currently enrolling
Study Sponsor:
American Medical Systems (AMS)
American Medical Systems (AMS)
Keywords :