Recruiting

Intraventricular Catheter System

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05970549

Conditions

Intraventricular Hemorrhage (IVH)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IRRAflow® Active Fluid Exchange System

Traditional extraventricular drain

Non-contrast head CTs

Study Details

Brief summary:

The purpose of this research study is to evaluate the safety and outcomes associated with the use of IRRAflow® System catheters in externally draining intracranial fluid to reduce intracranial pressure. This study will be comparing the IRRAflow® system to standard of care catheters used in the same procedure. The IRRAflow® system is FDA approved for this procedure.

Conditions

Intraventricular Hemorrhage (IVH)

Study ID

NCT05970549

Start date

Jun 14, 2022

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >=18 years of age
  • Intraventricular hemorrhage documented on head CT or MRI scan
  • Need of cerebrospinal fluid drainage
  • Indication for active treatment evaluated by the treating physicians
  • Signed informed consent obtained by patient or Legal Authorized Representative
  • Treatment possible within 72 hours of ictus

Exclusion Criteria:

  • Patient has fixed and dilated pupils
  • Pregnant or nursing women (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy)

Study Design

Enrollment

17 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IRRAflow with Active Fluid Exchange arm

The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria.

active comparator: Retrospective analysis of traditional external ventricular drains

The retrospective analysis will be performed on the last 60 traditional external ventricular drains.

Interventions

IRRAflow® Active Fluid Exchange System

All patients in the prospective arm of the study who met the study criteria and consent will be enrolled in the IRRAflow with Active Fluid Exchange arm.

Insertion of the IRRaflow catheter will be performed by neurosurgical attendings and residents who are privileged to place external ventricular drains and who have be instructed on how to appropriately connect the inserted IRRAflow catheter to the system. The on-site IRRAflow instructor will be present and available at all time to assist with any issues or questions should they arise.

Traditional extraventricular drain

The retrospective analysis will be performed on the last 60 traditional external ventricular drains.

Non-contrast head CTs

Non-contrast head CTs will be performed at least every 48 hours to document effectiveness. This frequency is standard, if not more frequent as necessary, for patients with external ventricular drainage and intraventricular hemorrhage. Scans are routinely obtained at this frequency to evaluate, for example: evacuation of hemorrhage, admission pathology, post-placement of catheters, any change in neurological exam, or after elevations in intracranial pressure. With these common CT scans we will be able to assess the efficacy of the IRRAflow catheter on the specified parameters. These scans are routinely performed due to this pathology and as such are covered as a necessity of the hospitalization by the insurance companies. MRI may be used in place of a CT scan if medically indicated as determined by the neurosurgical attending or neurocritical care attending according to standard of care for treatment of the neurological pathology.

Primary outcome measure

  • Residual blood volume [ Time Frame: At day 5 ]

Central Contacts and Locations

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10128

Contacts

Principal Investigator:

Christopher P Kellner

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

May 6, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-05-06.