Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
Collagen Matrix
Summary
Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
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 disclo…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
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.
Interventions
- OtherPost Market Study
Prospective case series without a concurrent comparator group.
Locations (2)
- Augusta UniversityAugusta, Georgia
- Massachusetts General HospitalBoston, Massachusetts