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NCT06649097 · ClinicalTrials.gov registry record
Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
A clinical trial of Intracranial Hemorrhage and Ventriculitis, sponsored by Christopher P Kellner.
- Recruiting
- Registry status
- 250
- Enrollment target
- 1
- Study location
NCT06649097: Recruiting study of Intracranial Hemorrhage and Ventriculitis, sponsored by Christopher P Kellner.
NCT06649097 is a study of Intracranial Hemorrhage and Ventriculitis that is actively recruiting participants, run by Christopher P Kellner. The registered enrollment target is 250 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06649097, a study of Intracranial Hemorrhage and Ventriculitis, is actively recruiting participants, sponsored by Christopher P Kellner.
- RECRUITING
- Registry status
- 250 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The residual blood volume at day 5 will be calculated to determine the efficacy of the IRRAflow system compared to other external ventricular drains (EVDs)
Conditions Studied
Interventions
- DEVICE IRRAflow® CNS (Active Fluid Exchange) System
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2025-09-25 |
| Est. Completion | 2031-07 |
What NCT06649097 shows while recruiting
NCT06649097 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap.
The record links to 3 conditions, with Intracranial Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which IRRAflow® CNS (Active Fluid Exchange) System is the first listed.
NCT06649097 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06649097 about?
NCT06649097 is a clinical study titled "Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System". 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.
What is the current status of trial NCT06649097?
This trial is currently recruiting. The enrollment target is 250 participants. The study started on 2025-09-25. Estimated completion is 2031-07.
What conditions does trial NCT06649097 study?
This clinical trial studies the following conditions: Intracranial Hemorrhage, Ventriculitis, Intracranial Abscess.
What interventions are being tested in trial NCT06649097?
The interventions under investigation include: IRRAflow® CNS (Active Fluid Exchange) System (DEVICE).
Who is sponsoring clinical trial NCT06649097?
This trial is sponsored by Christopher P Kellner, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06649097 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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