Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Post Market Study.
- Who it may be relevant to
- Registry conditions: Repair of Dura Mater. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
Overview
Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
Detailed description
A prospective, post-market, open label clinical study at a maximum of 8 sites, with an enrollment of 118 subjects. The primary endpoint of the study will be the rate of revision surgery. The presence of adverse events will be evaluated at each follow-up time point i.e. CSF leak, infection and Pseudomeningocele. Patients will have a follow-up evaluation at least at 8 weeks post initial surgery date (which align with the approximate resorption time of the device) where possible and as deemed necessary by a clinician.
No original patient records or personal identifying information will be disclosed to Collagen Matrix.
Interventions
- Other Post Market Study
Prospective case series without a concurrent comparator group.
Primary outcome measures
- Rate of Revision Surgery [Time frame: 8 weeks]
Secondary outcome measures (1)
- Rate of Adverse events [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- The general population will be included in the study where a dura substitute is required for the repair of dura mater.
Exclusion criteria
- Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Augusta University — Augusta
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT06802133 · CIP.057_DMOP