Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)
ConditionRepair of Dura Mater
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCollagen Matrix
About this trial
Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The general population will be included in the study where a dura substitute is required for the repair of dura mater.
Disqualifiers
Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.
Trial population
The general population will be included in the study where a dura substitute is required for the repair of dura mater
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Post Market Study
Other interventionProspective case series without a concurrent comparator group.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Rate of Revision Surgery
Adequate healing of dural defects without need for a revision surgery or second intervention
Time frame
8 weeksSecondary outcomes
1
Rate of Adverse events
Rate of product-related adverse events or complications
Time frame
8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov