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Clinical Trials/NCT03321266
NCT03321266CompletedNot Applicable

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

Cook Group Incorporated4 sites in 2 countries79 target enrollmentStarted: November 30, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
79
Locations
4
Primary Endpoint
Rate of fistula closure
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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