Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas
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
1 other identifier
observational
79
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2017
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedStudy Start
First participant enrolled
November 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2019
CompletedSeptember 25, 2019
September 1, 2019
1.7 years
October 20, 2017
September 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of fistula closure
Absence of drainage from the external fistula opening with complete epithelialization of the external fistula opening upon clinical exam.
up to 2 years
Study Arms (1)
Patients treated for a anorectal fistula
Patients who were treated for a anorectal fistula with a Biodesign Fistula plug
Interventions
The Cook Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of Anorectal fistulas.
Eligibility Criteria
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.
You may qualify if:
- Patients who have had surgery to treat anorectal fistula where the Biodesign® Fistula Plug was placed during the procedure
You may not qualify if:
- Patients not receiving the Biodesign® Fistula Plug for treatment of their anorectal fistula
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Louisville School of Medicine
Louisville, Kentucky, 40202, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808, United States
University Surgical Associates
Providence, Rhode Island, 02904, United States
St Josef's Hospital
Wiesbaden, 65189, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adal Saeed, MD
St Josef's Hospital, Wiesbaden
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2017
First Posted
October 25, 2017
Study Start
November 30, 2017
Primary Completion
August 29, 2019
Study Completion
August 29, 2019
Last Updated
September 25, 2019
Record last verified: 2019-09