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

Part of paid clinical trials in New York, New York.

Sponsor
Christopher P Kellner
Study ID
NCT06649097
Status
Recruiting
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Conditions

  • Intracranial Abscess
  • Intracranial Hemorrhage
  • Ventriculitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IRRAflow® CNS (Active Fluid Exchange) System — DEVICE
    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.

Study Details

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 Dates

Start date
Sep 25, 2025
Status verified
Oct 2025
Primary completion
Jan 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
250 participants (estimated)

Arms

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

Primary Outcome Measure

Residual blood volume by post bleed day 5 [ Time Frame: Post-procedure day 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Sukaina Davdani
[email protected]
212-241-2524
Sydney Edwards
[email protected]
(212) 241-2524
Christopher Kellner (PRINCIPAL_INVESTIGATOR)

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By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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