Monitoring the Use of Collagen Dura Membrane in the Post-market Phase
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Measurement of the occurrence of adverse event requiring surgical intervention
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with a dural defect requiring repair with a dural substitute.
Exclusion Criteria
- •There are no subject restrictions for the study other than patients with known allergy to bovine collagen products as specified in the contraindications of the Instructions for Use.
Outcomes
Primary Outcomes
Measurement of the occurrence of adverse event requiring surgical intervention
Time Frame: 6-9 months
Secondary Outcomes
- Adverse events i.e., infection, CSF leak and Pseudomeningocele(6-9 months)