Suturable DuraGen™ PMCF Study

Integra LifeSciences Corporation106 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

106

Conditions

Cerebrospinal Fluid Leak

Interventions

Suturable DuraGen™DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Baptist Medical Center

Jacksonville, Florida, United States

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Patient Outcome

Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure

Time frame: post-up to 90 days

Secondary Outcomes

Occurrence of Adverse Event

Adverse event that occurred between days 30-90 post-operatively

Time frame: Between days 30-90

Data from ClinicalTrials.gov

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