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

NCT06649097 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-10-28

No results posted yet for this study

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.

Conditions

  • Intracranial Hemorrhage
  • Ventriculitis
  • Intracranial Abscess

Interventions

DEVICE

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.

Sponsors & Collaborators

  • IRRAS

    collaborator INDUSTRY

  • Christopher P Kellner

    lead OTHER

Principal Investigators

  • Christopher Kellner · Icahn School of Medicine at Mount Sinai

  • Nicholas Brandmeir · West Virginia University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-25
Primary Completion
2031-01-31
Completion
2031-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06649097 on ClinicalTrials.gov