Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-29 @ 12:24 AM
Study NCT ID:
NCT04057157
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2019-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-market Assessment of Biodesign Dural Repair Grafts
Sponsor:
Cook Research Incorporated
Organization:
Study Overview
Official Title:
Post-market Clinical Data Collection Plan for the Biodesign® Dural and Duraplasty Grafts
Status:
COMPLETED
Status Verified Date:
2022-10
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 purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?: