Suturable DuraGen™ PMCF Study

April 18, 2024 updated by: Integra LifeSciences Corporation

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

260

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Neurosurgery service in Hospital

Description

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

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
Intervention / Treatment
Supratentorial Procedure Group
Subjects that have undergone a supratentorial procedure with the use of Suturable DuraGen™.
Device: Suturable DuraGen™
Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.
Infratentorial Procedure Group
Subjects that have undergone a infratentorial procedure with the use of Suturable DuraGen™.
Device: Suturable DuraGen™
Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.
Spinal Procedure Group
Subjects that have undergone a spinal procedure with the use of Suturable DuraGen™.
Device: Suturable DuraGen™
Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Outcome
Time Frame: post-up to 90 days
Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure
post-up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Adverse Event
Time Frame: Between days 30-90
Adverse event that occurred between days 30-90 post-operatively
Between days 30-90

Collaborators and Investigators

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

Sponsor

Integra LifeSciences Corporation

Investigators

  • Study Director: Andrew Tummon, Integra LifeSciences

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 (Actual)

April 28, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-DGSUT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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.

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