Post-Market Clinical Investigation Plan - Collagen Dura Membranes (DM & DMO)
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
- This is an observational study: the protocol does not assign a study treatment.
- 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 Dura Membrane in the Post-market Phase
Overview
Monitoring the Use of Collagen Dura Membrane in the Post-market phase
Detailed description
A multi-center clinical series of 110 patients treated with Collagen Dura Substitute Membrane (DuraMatrix \& DuraMatrix Onlay) for a dural defect in the dura mater will be evaluated prospectively. Patients will have follow-up time points through at least 6-9 months which align with the lifetime of the device. The primary endpoint of the study will be the presence of adverse events leakage that require surgical intervention, will be evaluated at each follow-up time point. The secondary endpoint of the study will be adverse events i.e. infection, Cerebrospinal fluid leak (CSF) and Pseudomeningocele. No patient records or personal identifying information will be disclosed to Collagen Matrix.
Primary outcome measures
- Measurement of the occurrence of adverse event requiring surgical intervention [Time frame: 6-9 months]
Secondary outcome measures (1)
- Adverse events i.e., infection, CSF leak and Pseudomeningocele [Time frame: 6-9 months]
Eligibility criteria
Inclusion criteria
- Patients with a dural defect requiring repair with a dural substitute.
Exclusion criteria
- There are no subject restrictions for the study other than patients with known allergy to bovine collagen products as specified in the contraindications of the Instructions for Use.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Medical Collagen of Wisconsin — Milwaukee
Identifiers
NCT: NCT06822920 · CIP.010