Suturable DuraGen™ PMCF Study

Completed

• Conditions: Cerebrospinal Fluid Leak
• Interventions: Device: Suturable DuraGen™

• Registration Number: NCT04923867
• Lead Sponsor: Integra LifeSciences Corporation

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 Timeline

• Study Start: 2021-04-28
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-11
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Supratentorial Procedure Group	Suturable DuraGen™	Subjects that have undergone a supratentorial procedure with the use of Suturable DuraGen™.
Spinal Procedure Group	Suturable DuraGen™	Subjects that have undergone a spinal procedure with the use of Suturable DuraGen™.
Infratentorial Procedure Group	Suturable DuraGen™	Subjects that have undergone a infratentorial procedure with the use of Suturable DuraGen™.

Primary Outcome Measures

Name	Time	Method
Patient Outcome	post-up to 90 days	Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure

Secondary Outcome Measures

Name	Time	Method
Occurrence of Adverse Event	Between days 30-90	Adverse event that occurred between days 30-90 post-operatively

Trial Locations

Locations (3)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Baptist Medical Center; 🇺🇸 Jacksonville, Florida, United States