NCT02225080

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 16, 2018

Completed
Last Updated

October 9, 2018

Status Verified

September 1, 2018

Enrollment Period

1.7 years

First QC Date

July 28, 2014

Results QC Date

November 15, 2017

Last Update Submit

September 10, 2018

Conditions

Dura Mater Nick Cut or TearSurgery

Outcome Measures

Primary Outcomes (1)

  • Patient's Outcome

    Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)

    Day 30

Secondary Outcomes (3)

  • Occurence of Adverse Event

    first 72 hours post-op

  • Occurence of Adverse Event

    between days 4-14

  • Occurence of Adverse Event

    Between days 15-30

Study Arms (1)

Duragen Secure

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Neurgosurgery service in Hospital

You may qualify if:

  • Patient who have undergone a neurosurgical procedure where DuraGen® Secure has been implanted

You may not qualify if:

  • Patient who does not agree to allow collection of his/her medical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hopital Lariboisière

Paris, France

Location

die Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario La Fe

Valencia, Spain

Location

National Hospital for Neurology and Neurosurgery

London, United Kingdom

Location

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

Title
Director, Global Clinical Affairs
Organization
Integra LifeSciences Corporation
andrew.tummon@integralife.com
609-936-5490

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2014

First Posted

August 25, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 9, 2018

Results First Posted

August 16, 2018

Record last verified: 2018-09

Locations

DE(1)FR(1)ES(2)GB(1)