Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-02 @ 10:14 AM
Study NCT ID:
NCT03321266
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2017-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas
Sponsor:
Cook Group Incorporated
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: