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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02225080
• Other study ID #: N-DURSEC-001
• Status: Completed
• Start date: October 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2018
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dura Mater Nick Cut or Tear
• Surgery

Locations

Country	Name	City	State
France	Hopital Lariboisière	Paris
Germany	die Charité - Universitätsmedizin Berlin	Berlin
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Fe	Valencia
United Kingdom	National Hospital for Neurology and Neurosurgery	London

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Countries where clinical trial is conducted

France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's Outcome	Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)	Day 30
Secondary	Occurence of Adverse Event	Adverse event that occured 72 hours post-operatively	first 72 hours post-op
Secondary	Occurence of Adverse Event	Adverse event that occured between days 4-14 post-operatively	between days 4-14
Secondary	Occurence of Adverse Event	Adverse event that occured between days 15-30 post-operatively	Between days 15-30