Monitoring the Use of Collagen Dura Regeneration Membrane - Repair (DMR) in the Post-market Phase.
A multi-center (up to 4 sites) clinical case series of 110 patients treated with Collagen Dura Regeneration Membrane - Repair (DMR) for a dural defect in the dura mater will be evaluated prospectively. The primary endpoint is the rate of adverse events related to the Subject Device requiring surgical intervention. Patients will have a follow-up evaluation post-operatively in line with standard or care of the study site, and 8 months after the initial surgery. No original patient records or personal identifying information will be disclosed to CMI.
Study Type
OBSERVATIONAL
Enrollment
110
Rate of Revision Surgery
Rate of adverse events related to the Subject Device requiring surgical intervention.
Time frame: at least one timepoint at 8 months or more post-surgery
Rate of Adverse Events
Intra-operative and post-operative adverse events (i.e., infection, CSF Leak, and Pseudomeningocele)
Time frame: at least one timepoint at 8 months or more post-surgery
Product Performance
Score of adequacy of product performance - 1 (poor) to 4 (excellent)
Time frame: at least one timepoint at 8 months or more post-surgery
Product Handling at Implantation
Score for product handling at implantation - 1 (poor) to 4 (excellent)
Time frame: Initial surgery
Product Adaptability at Implantation
Score for product adaptability at implantation - 1 (poor) to 4 (excellent)
Time frame: Initial surgery
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