Monitoring the Use of Collagen Dura Membrane - Repair (DMR) in the Post-market Phase
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- Rate of Revision Surgery
Study Overview
Brief Summary
Monitoring the Use of Collagen Dura Regeneration Membrane - Repair (DMR) in the Post-market Phase.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Rate of Revision Surgery
Time Frame: at least one timepoint at 8 months or more post-surgery
Rate of adverse events related to the Subject Device requiring surgical intervention.
Secondary Outcomes
- Rate of Adverse Events(at least one timepoint at 8 months or more post-surgery)
- Product Performance(at least one timepoint at 8 months or more post-surgery)
- Product Handling at Implantation(Initial surgery)
- Product Adaptability at Implantation(Initial surgery)