RecruitingNCT06649097

Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System

Sponsor

Christopher P Kellner

Enrollment

250 participants

Start Date

Sep 25, 2025

Study Type

OBSERVATIONAL

Conditions

Ventriculitis Intracranial Hemorrhage Intracranial Abscess

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called IRRAflow® CNS (Active Fluid Exchange) System for people with intracranial abscess, intracranial hemorrhage, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIRRAflow® 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

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NCT06649097

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