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Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

RecruitingNAAges 18 Years - anyAllIcahn School of Medicine at Mount Sinai
NCT05970549 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • IRRAflow® Active Fluid Exchange System
  • Traditional extraventricular drain
  • Non-contrast head CTs
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Where

1 site
Icahn School of Medicine at Mount Sinai
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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