Duragen® Secure Post Marketing Clinical Follow-up (PMCF)

Integra LifeSciences

Status: Completed

Conditions: Surgery; Dura Mater Nick Cut or Tear

Study type: Observational

Funder types: Industry

Identifiers

NCT02225080

N-DURSEC-001

Details and patient eligibility

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.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Duragen Secure

Description:

Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted