Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-01 @ 11:54 AM
Study NCT ID:
NCT01174992
Status:
COMPLETED
Last Update Posted:
2012-06-20
First Post:
2010-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
Sponsor:
Ethicon, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
Status:
COMPLETED
Status Verified Date:
2012-06
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 objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.
Detailed Description:
This is a randomized, multi-center controlled study evaluating the effectiveness of EVICEL\* as an adjunct to sutured dural closure compared to control to obtain an intraoperative watertight dural closure.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-016501-41 | EUDRACT_NUMBER | None | View |