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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03321266

Enrollment

Registered

2017-10-25

Start date

2017-11-30

Completion date

2019-08-29

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorectal Fistula

Keywords

Fistula plug

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.

Interventions

DEVICECook Biodesign® Fistula Plug

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026