Ignite Creation Date:
2025-12-18 @ 9:15 AM
Ignite Modification Date:
2025-12-23 @ 7:05 PM
Study NCT ID:
NCT00704340
Status:
None
Last Update Posted:
2017-09-07 00:00:00
First Post:
2008-06-23 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DuraSeal Sealant Post Market Study
Sponsor:
None
Organization:
Study Overview
Official Title:
DuraSeal Sealant Post Market Study
Status:
None
Status Verified Date:
2017-08
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:
DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as compared to control (defined as methods typically employed by surgeons to seal the dura).
Detailed Description:
None
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?: