Suturable DuraGen™ PMCF Study

Integra LifeSciences

Status: Completed

Conditions: Cerebrospinal Fluid Leak

Treatments: Device: Suturable DuraGen™

Study type: Observational

Funder types: Industry

Identifiers

NCT04923867

C-DGSUT-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

106 participants in 3 patient groups

Supratentorial Procedure Group

Description:

Subjects that have undergone a supratentorial procedure with the use of Suturable DuraGen™.

Treatment:

Device: Suturable DuraGen™

Infratentorial Procedure Group

Description:

Subjects that have undergone a infratentorial procedure with the use of Suturable DuraGen™.

Treatment:

Device: Suturable DuraGen™

Spinal Procedure Group

Description:

Subjects that have undergone a spinal procedure with the use of Suturable DuraGen™.

Treatment:

Device: Suturable DuraGen™