Post-market Clinical Investigation Plan: Collagen Dura Regeneration Membrane - Repair (DMR)
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 - Repair (DMR) in the Post-market Phase
Overview
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.
Primary outcome measures
- Rate of Revision Surgery [Time frame: at least one timepoint at 8 months or more post-surgery]
Secondary outcome measures (4)
- Rate of Adverse Events [Time frame: at least one timepoint at 8 months or more post-surgery]
- Product Performance [Time frame: at least one timepoint at 8 months or more post-surgery]
- Product Handling at Implantation [Time frame: Initial surgery]
- Product Adaptability at Implantation [Time frame: Initial surgery]
Eligibility criteria
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
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
- Cohort
Study locations
United States · 2 centers
- Rush University Medical Center — Chicago
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT07371091 · CIP.088