Repair of Dura Mater
Conditions
Brief summary
Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
Detailed description
A prospective, post-market, open label clinical study at a maximum of 8 sites, with an enrollment of 118 subjects. The primary endpoint of the study will be the rate of revision surgery. The presence of adverse events will be evaluated at each follow-up time point i.e. CSF leak, infection and Pseudomeningocele. Patients will have a follow-up evaluation at least at 8 weeks post initial surgery date (which align with the approximate resorption time of the device) where possible and as deemed necessary by a clinician. No original patient records or personal identifying information will be disclosed to Collagen Matrix.
Interventions
OTHERPost Market Study
Prospective case series without a concurrent comparator group.
Sponsors
Collagen Matrix
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* The general population will be included in the study where a dura substitute is required for the repair of dura mater.
Exclusion criteria
* Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Revision Surgery | 8 weeks | Adequate healing of dural defects without need for a revision surgery or second intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse events | 8 weeks | Rate of product-related adverse events or complications |
Countries
United States
Contacts
Primary ContactMeenakshi Paliwal
Backup ContactPeggy Hansen
Outcome results
None listed