Monitoring the Use of Collagen Dura Membrane - Suturable (DMS) in the Post-market Phase
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Rate of Adverse Events Requiring Surgical Intervention
Study Overview
Brief Summary
Monitoring the use of Collagen Dura Membrane - Suturable (DMS) in the post-market phase
Detailed Description
A prospective, post-market clinical study at a maximum of three sites, with an enrollment of 54 subjects. The primary endpoint of the study will be the rate of adverse events related to the Subject Device requiring surgical intervention. The date of each event will be recorded and assessed, including at least one timepoint of 9 months of more post-operatively. Secondary endpoints will include all adverse events (i.e., infection, CSF Leak, and Pseudomeningocele), score of adequacy of product performance, score for product handling at implantation, and score for product adaptability at implantation.
No original patient records or patient identifying information will be disclosed to Collagen Matrix.
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
- •Patient is 18 years or older
- •Patient of child-bearing potential is not pregnant or nursing
Exclusion Criteria
- •Patients with a known history of hypersensitivity to bovine derived materials
- •Patients that are non-English speaking
- •Subjects requiring Legally Authorized Representative
Outcomes
Primary Outcomes
Rate of Adverse Events Requiring Surgical Intervention
Time Frame: 9 months
Rate of adverse events related to subject device and requiring surgical intervention.
Secondary Outcomes
- Rate of Adverse Events(9 months)
- Score of adequacy of product performance(9 months)
- Score for Product Handling at Implantation(9 months)
- Score for Product Adaptability at Implantation(9 months)