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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 29, 2019

Interventions

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

Arms, Groups and Cohorts

  • Patients treated for a anorectal fistula
    • Patients who were treated for a anorectal fistula with a Biodesign Fistula plug

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cook Group Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Adal Saeed, MD, Principal Investigator, St Josef’s Hospital, Wiesbaden

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