Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923867
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2021-06-07
Brief Title:
Suturable DuraGen PMCF Study
Sponsor:
Integra LifeSciences Corporation
Organization:
Integra LifeSciences Corporation
Study Overview
Official Title:
A Multicenter Retrospective Post-Market Clinical Follow-Up Study to Evaluate the Performance and Safety of Suturable DuraGen
Status:
COMPLETED
Status Verified Date:
2024-09
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 primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen
Detailed Description:
This is a multicenter non-randomized non-interventional retrospective Post-Market Clinical Follow-up PMCF study to evaluate the occurrence of post-operative cerebrospinal fluid CSF leaks within 30 days and up to 90 days after use of Suturable DuraGen for a supratentorial infratentorial or spinal procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None