Ignite Creation Date:
2024-05-05 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00703131
Status:
COMPLETED
Last Update Posted:
2015-02-11
First Post:
2008-06-20
Brief Title:
Surgisis Anal Fistula Plug Study An Experience in Saudi Arabia
Sponsor:
Cook Group Incorporated
Organization:
Cook Group Incorporated
Study Overview
Official Title:
A Single-center Single Arm Prospective Study Evaluating the Surgisis Biodesign Anal Fistula Plug
Status:
COMPLETED
Status Verified Date:
2015-02
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:
SurgiSIS AFP
Brief Summary:
The Surgisis Anal Fistula Plug study is a clinical trial conducted in Saudi Arabia to study the safety and effectiveness of the Surgisis AFP Plug in the treatment of chronic anal fistulas
Detailed Description:
Up to 30 patients will be treated with the Surgisis Anal Fistula Plug using a standardized surgical procedure to plug their anal fistula Patients will be followed periodically until their 12-month follow-up
Study Oversight
Has Oversight DMC:
None
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?:
None