Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

NCT05970549 | Recruiting DMC FDA Device

• 1 other identifier: STUDY-21-01815
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Residual blood volume

  Residual blood volume on post bleed day 5

  At day 5

Secondary Outcomes (4)

• Serious adverse events

  up to 48 hours post-procedure

• Hospital quality metrics

  up to 48 hours post-procedure

• Length of stay in the NSICU

  up to 48 hours post-procedure

• Direct hospitalization costs

  up to 48 hours post-procedure

Study Arms (2)

IRRAflow with Active Fluid Exchange arm

EXPERIMENTAL

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

Device: IRRAflow® Active Fluid Exchange System; Procedure: Non-contrast head CTs

Retrospective analysis of traditional external ventricular drains

ACTIVE COMPARATOR

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

Device: Traditional extraventricular drain

Interventions

IRRAflow® Active Fluid Exchange System DEVICE

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.

Also known as: IRRAflow® CNS System

IRRAflow with Active Fluid Exchange arm

Traditional extraventricular drain DEVICE

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

Retrospective analysis of traditional external ventricular drains

Non-contrast head CTs PROCEDURE

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.

IRRAflow with Active Fluid Exchange arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• ClearPoint Neuro: collaborator
• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10128, United States

RECRUITING

Study Officials

• Christopher P Kellner, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Svendsen

CONTACT

(212) 241-3238; Emily.Svendsen@mountsinai.org

Sydney Edwards

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: There will be no masking involved. The proposed study is a single center retrospective and prospective cohort, controlled, single-center, phase 1 study evaluating the safety and radiographic outcomes associated use of the IRRAS catheter compared to standard of care external ventricular drains.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Neurosurgery

Model Details: The IRRAflow® System is an active fluid exchange system in which intracranial pressure (ICP) monitoring, active controlled irrigation and passive drainage are combined in one system. The system consists of 3 items; control unit (i) and two sterile disposable parts: (ii) Intelligent Digital Cassette (Tube Set) and (iii) dual-lumen Catheter.

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: June 14, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)