NCT06649097 Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
| NCT ID | NCT06649097 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Christopher P Kellner |
| Condition | Intracranial Hemorrhage |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-09-25 |
| Primary Completion | 2031-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2025-09-25 with a primary completion date of 2031-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study is a multi-center prospective cohort, controlled, phase 4 post-market registry evaluating the efficacy and radiographic outcomes associated with the use of the IRRAflow® Active Fluid Exchange System compared to standard of care external ventricular drains.
Eligibility Criteria
Inclusion criteria: * Age \>=18 years of age * Intracranial hemorrhage documented on head CT or MRI scan. * Indication for active fluid exchange evaluated by treating physician. * Signed informed consent obtained by patient or Legal Authorized Representative * Scheduled enrollment and treatment within 72 hours of last known well (LKW) Exclusion criteria: * GCS ≤ 5 * Pregnancy * Fixed and dilated pupil * Life-threatening medical condition
Contact & Investigator
Christopher Kellner
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06649097 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracranial Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06649097 currently recruiting?
Yes, NCT06649097 is actively recruiting participants. Contact the research team at Sukaina.Davdani@mountsinai.org for enrollment information.
Where is the NCT06649097 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06649097 clinical trial?
NCT06649097 is sponsored by Christopher P Kellner. The principal investigator is Christopher Kellner at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 250 participants.