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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03321266
Other study ID # 17-03
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Withdrawn NCT01913249 - Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula N/A
Completed NCT04357210 - Anal Sphincter Reconstruction After High Recurrent Anorectal Fistula Excision
Recruiting NCT01478139 - Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair Phase 3