Post-Market Clinical Investigation Plan - Collagen Dura Membranes (DM & DMO)
ConditionRepair of Dura Mater
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCollagen Matrix
About this trial
Monitoring the Use of Collagen Dura Membrane 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.
Disqualifiers
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.
Trial population
The subject device is intended for all patient populations. The following population is excluded from the study:- * Pregnant Women * Subjects requiring Legally Authorized Representative * Subjects under 18 years of age
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Measurement of the occurrence of adverse event requiring surgical intervention
Time frame
6-9 monthsSecondary outcomes
1
Adverse events i.e., infection, CSF leak and Pseudomeningocele
Time frame
6-9 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov