Monitoring the Use of Collagen Dura Membrane - Repair (DMR) in the Post-market Phase
Collagen Matrix
Summary
Monitoring the Use of Collagen Dura Regeneration Membrane - Repair (DMR) in the Post-market Phase.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with a dural defect requiring repair with a dural substitute as per routine clinical practice * Patient is 18 years or older * Patient of child-bearing potential is not pregnant or nursing * Participant is willing and able to provide consent Exclusion Criteria: * Patients with a known history of hypersensitivity to bovine derived materials * Patients that are non-English speaking * Patients requiring legal representation
Locations (2)
- Rush University Medical CenterChicago, Illinois
- Massachusetts General HospitalBoston, Massachusetts