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

NCT ID: NCT03321266

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-30

Study Completion Date

2019-08-29

Brief Summary

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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.

Detailed Description

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Conditions

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Anorectal Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients treated for a anorectal fistula

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

Cook Biodesign® Fistula Plug

Intervention Type DEVICE

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

Interventions

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Cook Biodesign® Fistula Plug

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adal Saeed, MD

Role: PRINCIPAL_INVESTIGATOR

St Josef's Hospital, Wiesbaden

Locations

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University of Louisville School of Medicine

Louisville, Kentucky, United States

Site Status

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, United States

Site Status

University Surgical Associates

Providence, Rhode Island, United States

Site Status

St Josef's Hospital

Wiesbaden, , Germany

Site Status

Countries

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United States Germany

Other Identifiers

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17-03

Identifier Type: -

Identifier Source: org_study_id

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