Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT06822920
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2025-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Market Clinical Investigation Plan - Collagen Dura Membranes (DM & DMO)
Sponsor:
Collagen Matrix
Organization:
Study Overview
Official Title:
Monitoring the Use of Collagen Dura Membrane in the Post-market Phase
Status:
RECRUITING
Status Verified Date:
2025-02
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:
DM&DMO
Brief Summary:
Monitoring the Use of Collagen Dura Membrane in the Post-market phase
Detailed Description:
A multi-center clinical series of 110 patients treated with Collagen Dura Substitute Membrane (DuraMatrix \& DuraMatrix Onlay) for a dural defect in the dura mater will be evaluated prospectively. Patients will have follow-up time points through at least 6-9 months which align with the lifetime of the device. The primary endpoint of the study will be the presence of adverse events leakage that require surgical intervention, will be evaluated at each follow-up time point. The secondary endpoint of the study will be adverse events i.e. infection, Cerebrospinal fluid leak (CSF) and Pseudomeningocele. No patient records or personal identifying information will be disclosed to Collagen Matrix.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: