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

September 24, 2019 updated by: Cook Group Incorporated

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Wiesbaden, Germany, 65189
        • St Josef's Hospital
  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville School of Medicine
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Regional Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • University Surgical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients implanted with the Cook Biodesign Fistula Plug at each of the participating institutions through 31 Dec 2016 will be included in the retrospective data collection regardless of outcome. A patient must have at least one follow-up visit.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated for a anorectal fistula
Patients who were treated for a anorectal fistula with a Biodesign Fistula plug
Device: Cook Biodesign® Fistula Plug
The Cook Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of Anorectal fistulas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Adal Saeed, MD, St Josef's Hospital, Wiesbaden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2017

Primary Completion (Actual)

August 29, 2019

Study Completion (Actual)

August 29, 2019

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (Actual)

October 25, 2017

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anorectal Fistula

Clinical Trials on Cook Biodesign® Fistula Plug

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe