NCT06649097

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Christopher P Kellner · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The IRRAflow system offers automated irrigation, controlled drainage, and ICP monitoring all in one system for the treatment of intracranial hemorrhage - \[Intracerebral hemorrhage (ICH), Intraventricular hemorrhage (IVH), Subarachnoid hemorrhage (SAH), Subdural hematoma (SDH)\], intracranial abscess, and ventriculitis. The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria. All patients enrolled in the trial will receive additional supportive and medical treatment by choice of the treating physician and in accordance with standard of care. Such treatment includes but is not limited to neurointensive care, neuromonitoring, and surgical or endovascular occlusion of identified sources of intracranial hemorrhage (e.g. vascular anomalies, aneurysms, etc.).

Conditions

• Intracranial Hemorrhage
• Ventriculitis
• Intracranial Abscess

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-25
• Primary completion: 2031-01-01
• Completion: 2031-07-01
• First posted: 2024-10-18
• Last updated: 2025-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study