Recruiting

IRRAflow

Sponsor:

Christopher P Kellner

Code:

NCT06649097

Conditions

Intracranial Hemorrhage

Ventriculitis

Intracranial Abscess

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IRRAflow® CNS (Active Fluid Exchange) System

Study Details

Brief 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

Study ID

NCT06649097

Start date

Sep 25, 2025

Status verified date

Oct, 2025

Completion date

Jul, 2031

Anticipated

Primary completion date

Jan, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Age >=18 years of age
  • Intracranial hemorrhage documented on head CT or MRI scan.
  • Indication for active fluid exchange evaluated by treating physician.
  • Signed informed consent obtained by patient or Legal Authorized Representative
  • Scheduled enrollment and treatment within 72 hours of last known well (LKW)

Exclusion criteria:

  • GCS ≤ 5
  • Pregnancy
  • Fixed and dilated pupil
  • Life-threatening medical condition

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

IRRAflow device

All patients enrolled into the study will undergo treatment with the IRRAflow device

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.

Primary outcome measure

  • Residual blood volume by post bleed day 5 [ Time Frame: Post-procedure day 5 ]
  • Utility weighted modified Rankin Score [ Time Frame: End of study, at 6 months ]

Central Contacts and Locations

Central contacts

Sukaina Davdani

(212) 241-2524Sukaina.Davdani@mountsinai.org

Sydney Edwards

(212) 241-2524Sydney.Edwards@mountsinai.org

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Sukaina Davdani

212-241-2524Sukaina.Davdani@mountsinai.org

Sydney Edwards

(212) 241-2524Sydney.Edwards@mountsinai.org

Principal Investigator:

Christopher Kellner

More Information

Sponsor

Christopher P Kellner

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christopher P Kellner on 2025-10-28.