RecruitingNot Applicable

Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

United States17 participantsStarted 2022-06-14

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Residual blood volume

Timeframe: At day 5

Trial details

NCT IDNCT05970549

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Emily Svendsen

(212) 241-3238 Emily.Svendsen@mountsinai.org

View on ClinicalTrials.gov More Intraventricular Hemorrhage (IVH) trials