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

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.

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Key information

Conditions

Anorectal Fistula Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Sex eligibility

All sexes

Study type

Observational

Primary location

St Josef's Hospital, Wiesbaden, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cook Biodesign® Fistula Plug

Device

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

Primary outcomes

Rate of fistula closure

Time frame: up to 2 years

Absence of drainage from the external fistula opening with complete epithelialization of the external fistula opening upon clinical exam.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Oct 25, 2017
Registry last updated: Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed