Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

Recruiting now · Not applicable

Conditions studied: Intraventricular Hemorrhage (IVH)

In brief

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.

Key facts

Study ID

NCT05970549

Run by

Icahn School of Medicine at Mount Sinai

People needed

17

Starts

2022-06-14

Expected to finish

2026-12-31

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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