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

Completed

• Conditions: Surgery; Dura Mater Nick Cut or Tear

• Registration Number: NCT02225080
• Lead Sponsor: Integra LifeSciences Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-25
• Study Start: 2014-10
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2017-11-15
• Results First Submitted QC: 2017-11-15
• Results First Posted: 2018-08-16
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient's Outcome	Day 30	Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)

Secondary Outcome Measures

Name	Time	Method
Occurence of Adverse Event	Between days 15-30	Adverse event that occured between days 15-30 post-operatively

Trial Locations

Locations (5)

Hopital Lariboisière; 🇫🇷 Paris, France

die Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

National Hospital for Neurology and Neurosurgery; 🇬🇧 London, United Kingdom

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain