NCT04923867CompletedNot Applicable
A Multicenter, Retrospective, Post-Market Clinical Follow-Up Study to Evaluate the Performance and Safety of Suturable DuraGen™
Integra LifeSciences Corporation3 sites in 1 country260 target enrollmentStarted: April 28, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 260
- Locations
- 3
- Primary Endpoint
- Patient Outcome
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is between 18 and 80 years of age
- •Subject has undergone either a supratentorial, an infratentorial, or a spinal procedure with the use of Suturable DuraGen™ prior to trial initiation
- •Availability of post-operative assessment results.
Exclusion Criteria
- •There are no exclusionary criteria for this study population
Outcomes
Primary Outcomes
Patient Outcome
Time Frame: post-up to 90 days
Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure
Secondary Outcomes
- Occurrence of Adverse Event(Between days 30-90)
Investigators
Study Sites (3)
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