Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas
Completed
- Conditions
- Anorectal Fistula
- Interventions
- Device: Cook Biodesign® Fistula Plug
- Registration Number
- NCT03321266
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-\[X\]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for statistical analysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
Inclusion Criteria
- Patients who have had surgery to treat anorectal fistula where the Biodesign® Fistula Plug was placed during the procedure
Exclusion Criteria
- Patients not receiving the Biodesign® Fistula Plug for treatment of their anorectal fistula
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients treated for a anorectal fistula Cook Biodesign® Fistula Plug Patients who were treated for a anorectal fistula with a Biodesign Fistula plug
- Primary Outcome Measures
Name Time Method Rate of fistula closure up to 2 years Absence of drainage from the external fistula opening with complete epithelialization of the external fistula opening upon clinical exam.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
University of Louisville School of Medicine
🇺🇸Louisville, Kentucky, United States
University Surgical Associates
🇺🇸Providence, Rhode Island, United States
St Josef's Hospital
🇩🇪Wiesbaden, Germany
Our Lady of the Lake Regional Medical Center
🇺🇸Baton Rouge, Louisiana, United States