Repair of Dura Mater
Conditions
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.
Interventions
OTHERPost-market Study
Prospective case series without a concurrent comparator group.
Sponsors
Baptist Health South Florida
Collagen Matrix
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse Events Requiring Surgical Intervention | 9 months | Rate of adverse events related to subject device and requiring surgical intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse Events | 9 months | Rate of all product related adverse events or complications. |
| Score of adequacy of product performance | 9 months | rated yes/no by clinician |
| Score for Product Handling at Implantation | 9 months | Rated on a scale from 1 (poor) to 4 (excellent) by clinician. |
| Score for Product Adaptability at Implantation | 9 months | Rate on a scale of 1 (poor) to 4 (excellent) by clinician. |
Countries
United States
Contacts
Primary ContactMeenakshi Paliwal
Backup ContactPeggy Hansen
Outcome results
None listed