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

NCT02225080 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2018-10-09

Study results available
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Summary

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.

Conditions

  • Dura Mater Nick Cut or Tear
  • Surgery

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02225080 on ClinicalTrials.gov