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Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Sponsor: Christopher P Kellner
Summary
The study is a multi-center prospective cohort, controlled, phase 4 post-market registry evaluating the efficacy and radiographic outcomes associated with the use of the IRRAflow® Active Fluid Exchange System compared to standard of care external ventricular drains.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2025-09-25
Completion Date
2031-07
Last Updated
2025-10-28
Healthy Volunteers
No
Interventions
IRRAflow® CNS (Active Fluid Exchange) System
The IRRAflow system offers automated irrigation, controlled drainage and intracranial pressure (ICP) monitoring all in one system. It consists of three main parts - IRRAflow 2.0 Catheter, IRRAflow Tube Set, IRRAflow Control Unit.
Locations (1)
Icahn School of Medicine at Mount Sinai
New York, New York, United States