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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

18-75 Years
All
All
All

Not accepting

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?

Yes

Inclusion Criteria

- Patient who have undergone a neurosurgical procedure where DuraGen® Secure has been implanted

No

Exclusion Criteria

- Patient who does not agree to allow collection of his/her medical data