Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2026-01-01 @ 8:24 AM
Study NCT ID:
NCT01290666
Status:
TERMINATED
Last Update Posted:
2017-01-13
First Post:
2011-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair
Sponsor:
W.L.Gore & Associates
Organization:
Study Overview
Official Title:
Multicenter,Prospective, Observational Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair
Status:
TERMINATED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sufficient patient population achieved; decision not due to product complaints.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary outcome variable is healing at the final follow up visit.
Detailed Description:
The primary purpose of this prospective, multicenter, observational, single arm study is to further substantiate efficacy of the GORE® BIO-A® Fistula Plug when used as a soft tissue reinforcement of anal fistula repair and healing.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: