Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05970549

Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-05-06

17

Participants Needed

1

Research Sites

237 weeks

Total Duration

On this page

Sponsors

I

Icahn School of Medicine at Mount Sinai

Lead Sponsor

C

ClearPoint Neuro

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3E=18 years
  • Documented intraventricular hemorrhage on head CT or MRI scan
  • Need for cerebrospinal fluid drainage
  • Active treatment indicated by treating physicians
  • Signed informed consent from patient or legal representative
  • Treatment possible within 72 hours of hemorrhage onset
Not Eligible

You will not qualify if you...

  • Fixed and dilated pupils
  • Pregnant or nursing women (fertile female participants must have a valid pregnancy test)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10128

Actively Recruiting

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Research Team

E

Emily Svendsen

CONTACT

S

Sydney Edwards

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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