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Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

Who can join

Ages 18 and older · All sexes

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)

About the study

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.

What is being tested

• IRRAflow® Active Fluid Exchange System (device)
• Traditional extraventricular drain (device)
• Non-contrast head CTs (procedure)

Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 17 · Started: Jun 14, 2022

Contact the study team

• Emily Svendsen · Phone: (212) 241-3238
• Sydney Edwards · Phone: (212) 241-2524

Official record on ClinicalTrials.gov — NCT05970549

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.