Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
Completed
Conditions studied: Fecal Incontinence
In brief
The purpose of this observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.
Key facts
- Study ID
- NCT01647906
- Run by
- Bausch Health Americas, Inc.
- People needed
- 277
- Starts
- 2012-05-31
- Expected to finish
- 2018-09-15
- Last updated by the study team
- 2019-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic — Scottsdale, Arizona, United States
- Colon and Rectal Medical Services — Los Angeles, California, United States
- University of California Irvine Medical Center — Orange, California, United States
- Galliano Private Practice — Port Charlotte, Florida, United States
- USF Health — Tampa, Florida, United States
- North Pinellas Surgical Institute — Tarpon Springs, Florida, United States
- Cleveland Clinic Florida Health — Weston, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Georgia Regents Research Institute — Augusta, Georgia, United States
- The Iowa Clinic — Des Moines, Iowa, United States
- Colon and Rectal Surgery Associates, Ltd. — Minneapolis, Minnesota, United States
- Colon and Rectal Surgery, LLC — Omaha, Nebraska, United States
- North Shore Long Island Jewish Health Systems — Huntington, New York, United States
- NYU Langone Medical Center — New York, New York, United States
- Mount Sinai Medical Center — New York, New York, United States
- Cleveland Clinic Foundation Digestive Disease Institute — Cleveland, Ohio, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- Colon and Rectal Research Foundation — Allentown, Pennsylvania, United States
- Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
- University of Vermont Medical Center — Burlington, Vermont, United States
Full record on ClinicalTrials.gov
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