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

September 10, 2018 updated by: Integra LifeSciences Corporation
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Hopital Lariboisiere
  • Germany
      • Berlin, Germany
        • die Charité - Universitätsmedizin Berlin
  • Spain
      • Madrid, Spain
        • Hospital Universitario 12 De Octubre
      • Valencia, Spain
        • Hospital Universitario La Fe
  • United Kingdom
      • London, United Kingdom
        • National Hospital For Neurology and Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Neurgosurgery service in Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Duragen Secure
Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of Adverse Event
Time Frame: first 72 hours post-op
Adverse event that occured 72 hours post-operatively
first 72 hours post-op
Occurence of Adverse Event
Time Frame: between days 4-14
Adverse event that occured between days 4-14 post-operatively
between days 4-14
Occurence of Adverse Event
Time Frame: Between days 15-30
Adverse event that occured between days 15-30 post-operatively
Between days 15-30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integra LifeSciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 28, 2014

First Submitted That Met QC Criteria

August 22, 2014

First Posted (Estimate)

August 25, 2014

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • N-DURSEC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe