Post-market Clinical Investigation Plan: Collagen Dura Regeneration Membrane - Repair (DMR)
ConditionRepair of Dura Mater
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCollagen Matrix
About this trial
Monitoring the Use of Collagen Dura Regeneration Membrane - Repair (DMR) in the Post-market Phase.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with a known history of hypersensitivity to bovine derived materials
Patients that are non-English speaking
Patients requiring legal representation
Trial population
All patients with a dural defect requiring repair with a dural substitute.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Rate of Revision Surgery
Rate of adverse events related to the Subject Device requiring surgical intervention.
Time frame
at least one timepoint at 8 months or more post-surgerySecondary outcomes
1
Rate of Adverse Events
Intra-operative and post-operative adverse events (i.e., infection, CSF Leak, and Pseudomeningocele)
Time frame
at least one timepoint at 8 months or more post-surgery2
Product Performance
Score of adequacy of product performance - 1 (poor) to 4 (excellent)
Time frame
at least one timepoint at 8 months or more post-surgery3
Product Handling at Implantation
Score for product handling at implantation - 1 (poor) to 4 (excellent)
Time frame
Initial surgery4
Product Adaptability at Implantation
Score for product adaptability at implantation - 1 (poor) to 4 (excellent)
Time frame
Initial surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Collagen Matrix
Lead sponsor
Stryker Nordic
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: