NCT06649097 · Christopher P Kellner
Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
(CRYSTAL)
What this study is about
The study is a multi-center forward-looking group of participants, controlled, phase 4 post-market registry evaluating the effectiveness and radiographic outcomes associated with the use of the IRRAflow® Active Fluid Exchange System compared to the usual treatment external ventricular drains.
View original scientific description
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.
Interventions
DEVICE
IRRAflow® CNS (Active Fluid Exchange) System
The IRRAflow system offers automated irrigation, controlled drainage and intracranial pressure (ICP) monitoring all in one system. It consists of three main parts - IRRAflow 2.0 Catheter, IRRAflow Tube Set, IRRAflow Control Unit.
Primary outcome measures
Residual blood volume by post bleed day 5
Time frame: Post-procedure day 5
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)
Utility weighted modified Rankin Score
Time frame: End of study, at 6 months
Modified Rankin Scale score at 6 months will be collected to determine patient functional outcomes at 6 months. Scores range from 0 to 6, with 0 indicating no disability and 6 indicating death
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Fixed and dilated pupil
- Life-threatening medical condition
Where
- New York, New York
Collaborators
IRRAS
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 28, 2025 · Source of record for eligibility and locations