Using a new catheter system to treat intraventricular hemorrhage
Official title: DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage
Run by Icahn School of Medicine at Mount Sinai · NCT05970549 · Data updated 2026-11-12
This study is testing a new catheter system to see if it can safely and effectively drain fluid in the brains of patients with intraventricular hemorrhage, compared to standard catheters.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 17 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | June 14, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT05970549 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with documented intraventricular hemorrhage requiring cerebrospinal fluid drainage.
✕Probably not a fit
Patients with fixed and dilated pupils or those who are pregnant or nursing may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research evaluates the safety and effectiveness of the IRRAflow® System catheters for draining intracranial fluid in patients with intraventricular hemorrhage (IVH). The study compares the IRRAflow® system to standard catheters used for the same purpose, focusing on reducing intracranial pressure. The study involves monitoring various parameters such as intracranial pressure and cerebral perfusion pressure to optimize patient outcomes. Participants will be treated within 72 hours of their condition onset, and informed consent will be obtained from them or their legal representatives.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of intracranial pressure in patients with IVH, potentially reducing morbidity and mortality.
How similar studies have gone: While the IRRAflow® system is FDA approved, the specific application in this study is novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Icahn School of Medicine at Mount Sinai
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Christopher P Kellner, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Emily Svendsen
- Email: Emily.Svendsen@mountsinai.org
- Phone: (212) 241-3238
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.