Cerebrospinal Fluid Leak
Conditions
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.
Interventions
DEVICESuturable DuraGen™
Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Outcome | post-up to 90 days | Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Adverse Event | Between days 30-90 | Adverse event that occurred between days 30-90 post-operatively |
Countries
United States
Outcome results
None listed