Intraventricular Catheter System for IVH

Description

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 Overview

Study Details

Study overview

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.

DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

Intraventricular Catheter System for IVH

Condition
Intraventricular Hemorrhage (IVH)
Intervention / Treatment

-

Contacts and Locations

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Icahn School of Medicine at Mount Sinai,

Christopher P Kellner, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2025-12