Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas

Anorectal Fistula Clinical Trial

Official title:

A Retrospective Review of the Use of the Cook Biodesign® Fistula Plug (C-FPS-0.2, C-FPS-0.4, and C-FPS-0.7) to Treat Anorectal Fistulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03321266
• Other study ID #: 17-03
• Status: Completed
• Start date: November 30, 2017
• Est. completion date: August 29, 2019

Study information

• Verified date: September 2019
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anorectal Fistula
• Fistula
• Rectal Fistula

Intervention

Device:
• Cook Biodesign® Fistula Plug
The Cook Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of Anorectal fistulas.

Locations

Country	Name	City	State
Germany	St Josef's Hospital	Wiesbaden
United States	Our Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana
United States	University of Louisville School of Medicine	Louisville	Kentucky
United States	University Surgical Associates	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Cook Group Incorporated

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of fistula closure	Absence of drainage from the external fistula opening with complete epithelialization of the external fistula opening upon clinical exam.	up to 2 years