Duragen® Secure Post Marketing Clinical Follow-up (PMCF)
Sponsored by Integra LifeSciences Corporation
About this trial
Last updated 7 years ago
Study ID
N-DURSEC-001
Status
Completed
Type
Observational
Placebo
No
Accepting
All
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 9 years ago
What is this trial about?
The purpose of this study is to gather information about post-market performance of DuraGen
Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market
clinical data to evaluate the presence of unintended residual risks associated with the use
of DuraGen Secure that were not anticipated or identified in the animal studies, bench
studies or clinical evaluation report.
What are the participation requirements?
Inclusion Criteria
- Patient who have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
Exclusion Criteria
- Patient who does not agree to allow collection of his/her medical data