Suturable DuraGen™ PMCF Study

Cerebrospinal Fluid Leak Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04923867
• Other study ID #: C-DGSUT-001
• Status: Active, not recruiting
• Start date: April 28, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak

Intervention

Device:
• Suturable DuraGen™
Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Baptist Medical Center	Jacksonville	Florida
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Outcome	Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure	post-up to 90 days
Secondary	Occurrence of Adverse Event	Adverse event that occurred between days 30-90 post-operatively	Between days 30-90