The Primary Objective of the Study is to Retrospectively Evaluate the Safety and Efficacy of the Suturable DuraGen™

Brief Title

The Primary Objective of the Study is to Retrospectively Evaluate the Safety and Efficacy of the Suturable DuraGen™

Official Title

A Multicenter, Retrospective, Post-Market Clinical Follow-Up Study to Evaluate the Performance and Safety of Suturable DuraGen™

Brief Summary

      The primary goal of this study is to retrospectively collect data on the safety and efficacy
      of Suturable DuraGen™.
    

Detailed Description

      This is a multicenter, non-randomized, non-interventional, retrospective Post-Market Clinical
      Follow-up (PMCF) study to evaluate the occurrence of post-operative cerebrospinal fluid (CSF)
      leaks within 30 days (and up to 90 days) after use of Suturable DuraGen™ for a
      supratentorial, infratentorial, or spinal procedure.
    


Study Type

Observational


Primary Outcome

Patient Outcome

Secondary Outcome

 Occurrence of Adverse Event

Condition

Cerebrospinal Fluid Leak

Intervention

Suturable DuraGen™

Study Arms / Comparison Groups

 Supratentorial Procedure Group
Description:  Subjects that have undergone a supratentorial procedure with the use of Suturable DuraGen™.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

260

Start Date

April 28, 2021

Completion Date

December 31, 2022

Primary Completion Date

December 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Subject is between 18 and 80 years of age

          2. Subject has undergone either a supratentorial, an infratentorial, or a spinal
             procedure with the use of Suturable DuraGen™ prior to trial initiation

          3. Availability of post-operative assessment results.

        Exclusion Criteria:

        1. There are no exclusionary criteria for this study population
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Andrew Tummon, 732-647-5017, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04923867

Organization ID

C-DGSUT-001


Responsible Party

Sponsor

Study Sponsor

Integra LifeSciences Corporation


Study Sponsor

Andrew Tummon, Study Director, Integra LifeSciences


Verification Date

October 2021