Monitoring the use of Collagen Dura Membrane - Suturable (DMS) in the post-market phase
Patients with a dural defect requiring repair with a dural substitute
Patient is 18 years or older
Patient of child-bearing potential is not pregnant or nursing
Patients with a known history of hypersensitivity to bovine derived materials
Patients that are non-English speaking
Subjects requiring Legally Authorized Representative
The general population will be included in the study where a dura substitute is required for the repair of dura mater.
Cohort
Prospective
Post-market Study
Other interventionProspective case series without a concurrent comparator group.
Rate of Adverse Events Requiring Surgical Intervention
Rate of adverse events related to subject device and requiring surgical intervention.
Rate of Adverse Events
Rate of all product related adverse events or complications.
Score of adequacy of product performance
rated yes/no by clinician
Score for Product Handling at Implantation
Rated on a scale from 1 (poor) to 4 (excellent) by clinician.
Score for Product Adaptability at Implantation
Rate on a scale of 1 (poor) to 4 (excellent) by clinician.
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Collagen Matrix
Lead sponsor
Baptist Health South Florida
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
