Intraventricular Hemorrhage (IVH)DIVENCT05970549
Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage
A study testing IRRAflow® Active Fluid Exchange System, Traditional extraventricular drain and Non-contrast head CTs in people with Intraventricular Hemorrhage (IVH), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraventricular Hemorrhage (IVH)
- What is being tested?
- IRRAflow® Active Fluid Exchange System, Traditional extraventricular drain and Non-contrast head CTs
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10128
Christopher P Kellner, MD, 212-241-2606, christopher.kellner@mountsinai.org
Trevor Hardigan, MD PhD, 212-241-2606, trevor.hardigan@mountsinai.org
About this study
Official title: DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage
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.
Read the detailed description
Intracranial hemorrhagic conditions can rapidly cause brain damage and often considered life- threatening. Of these, Intracerebral hemorrhagic (ICH) is the most common type of hemorrhagic stroke and is associated with higher rates of morbidity and mortality than all stroke subtypes.
Management of hemorrhagic patients is typically orchestrated by neurosurgeons and neuro-intensivists. Comprehensive care should include surveillance and monitoring of Intra Cranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and hemodynamic function. Furthermore, prevention of infection, complications of immobility through positioning and mobilization within physiological tolerance play an important role in optimizing outcomes after ICH.
There are multiple approaches to facilitating Cerebrospinal Fluid (CSF) drainage and monitor ICP. Routinely, intracranial pressure is measured by use of devices inserted into the brain parenchyma or cerebral ventricles. A Ventricular Catheter (VC) inserted into the lateral ventricle allows for drainage of CSF to help reduce ICP. Although CSF drainage is a vital sequence in patient management, there are reported risks including infection and limitations related to erroneous readings associated with current ICP monitors. Physicians lack the appropriate tools to employ active intermittent aspiration and drainage with continuous ICP monitoring.
The current clinical study is being initiated to evaluate the hypothesis that active irrigation by IRRAflow will reduce the time needed for clearance of intraventricular blood from intraventricular space.
- Conditions
- Intraventricular Hemorrhage (IVH)
- Being tested
- IRRAflow® Active Fluid Exchange System, Traditional extraventricular drain, Non-contrast head CTs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRRAflow® Active Fluid Exchange SystemDevice
Also called IRRAflow® CNS System
All patients in the prospective arm of the study who met the study criteria and consent will be enrolled in the IRRAflow with Active Fluid Exchange arm.
Insertion of the IRRaflow catheter will be performed by neurosurgical attendings and residents who are privileged to place external ventricular drains and who have be instructed on how to appropriately connect the inserted IRRAflow catheter to the system. The on-site IRRAflow instructor will be present and available at all time to assist with any issues or questions should they arise.
Traditional extraventricular drainDevice
The retrospective analysis will be performed on the last 60 traditional external ventricular drains.
Non-contrast head CTsProcedure or surgery
Non-contrast head CTs will be performed at least every 48 hours to document effectiveness. This frequency is standard, if not more frequent as necessary, for patients with external ventricular drainage and intraventricular hemorrhage. Scans are routinely obtained at this frequency to evaluate, for example: evacuation of hemorrhage, admission pathology, post-placement of catheters, any change in neurological exam, or after elevations in intracranial pressure. With these common CT scans we will be able to assess the efficacy of the IRRAflow catheter on the specified parameters. These scans are routinely performed due to this pathology and as such are covered as a necessity of the hospitalization by the insurance companies. MRI may be used in place of a CT scan if medically indicated as determined by the neurosurgical attending or neurocritical care attending according to standard of care for treatment of the neurological pathology.
| Study group | Role | What they receive |
|---|---|---|
| IRRAflow with Active Fluid Exchange arm | Experimental | The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria. Receives: Device: IRRAflow® Active Fluid Exchange System; Procedure: Non-contrast head CTs |
| Retrospective analysis of traditional external ventricular drains | Active comparator | The retrospective analysis will be performed on the last 60 traditional external ventricular drains. Receives: Device: Traditional extraventricular drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual blood volume
Residual blood volume on post bleed day 5
Measured: At day 5
Secondary outcomes (4)
Serious adverse events
Number of serious adverse events
Measured: up to 48 hours post-procedure
Hospital quality metrics
Length of stay in the NSICU as a quality metrics
Measured: up to 48 hours post-procedure
Length of stay in the NSICU
Length of hospital stay in the as a quality metrics
Measured: up to 48 hours post-procedure
Direct hospitalization costs
Direct hospitalization costs
Measured: up to 48 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start14 Jun 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraventricular Hemorrhage (IVH)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The IRRAflow® System is an active fluid exchange system in which intracranial pressure (ICP) monitoring, active controlled irrigation and passive drainage are combined in one system. The system consists of 3 items; control unit (i) and two sterile disposable parts: (ii) Intelligent Digital Cassette (Tube Set) and (iii) dual-lumen Catheter.
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- ClearPoint Neuro
- Responsible party
- Principal investigator, Christopher P Kellner, Icahn School of Medicine at Mount Sinai
- Investigators
- Christopher P Kellner, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970549
- Sponsor's protocol ID
- STUDY-21-01815
- Acronym
- DIVE
- Status last verified
- Jan 2026
- First submitted
- 24 Jul 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: In order to minimize any privacy risks to the patients participating, IPD data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage
- ClinicalTrials.gov ID
- NCT05970549
- Acronym / sponsor ID
- DIVE / STUDY-21-01815
- Conditions
- Intraventricular Hemorrhage (IVH)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- ClearPoint Neuro
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intracranial hemorrhagic conditions can rapidly cause brain damage and often considered life- threatening. Of these, Intracerebral hemorrhagic (ICH) is the most common type of hemorrhagic stroke and is associated with higher rates of morbidity and mortality than all stroke subtypes.
Management of hemorrhagic patients is typically orchestrated by neurosurgeons and neuro-intensivists. Comprehensive care should include surveillance and monitoring of Intra Cranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and hemodynamic function. Furthermore, prevention of infection, complications of immobility through positioning and mobilization within physiological tolerance play an important role in optimizing outcomes after ICH.
There are multiple approaches to facilitating Cerebrospinal Fluid (CSF) drainage and monitor ICP. Routinely, intracranial pressure is measured by use of devices inserted into the brain parenchyma or cerebral ventricles. A Ventricular Catheter (VC) inserted into the lateral ventricle allows for drainage of CSF to help reduce ICP. Although CSF drainage is a vital sequence in patient management, there are reported risks including infection and limitations related to erroneous readings associated with current ICP monitors. Physicians lack the appropriate tools to employ active intermittent aspiration and drainage with continuous ICP monitoring.
The current clinical study is being initiated to evaluate the hypothesis that active irrigation by IRRAflow will reduce the time needed for clearance of intraventricular blood from intraventricular space.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The IRRAflow® System is an active fluid exchange system in which intracranial pressure (ICP) monitoring, active controlled irrigation and passive drainage are combined in one system. The system consists of 3 items; control unit (i) and two sterile disposable parts: (ii) Intelligent Digital Cassette (Tube Set) and (iii) dual-lumen Catheter.
| Arm | Type | Receives |
|---|---|---|
| IRRAflow with Active Fluid Exchange arm | Experimental | Device: IRRAflow® Active Fluid Exchange System, Procedure: Non-contrast head CTsThe analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria. |
| Retrospective analysis of traditional external ventricular drains | Active comparator | Device: Traditional extraventricular drainThe retrospective analysis will be performed on the last 60 traditional external ventricular drains. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRRAflow® Active Fluid Exchange SystemAlso: IRRAflow® CNS SystemAll patients in the prospective arm of the study who met the study criteria and consent will be enrolled in the IRRAflow with Active Fluid Exchange arm. Insertion of the IRRaflow catheter will be performed by neurosurgical attendings and residents who are privileged to place external ventricular drains and who have be instructed on how to appropriately connect the inserted IRRAflow catheter to the system. The on-site IRRAflow instructor will be present and available at all time to assist with any issues or questions should they arise. | Device | IRRAflow with Active Fluid Exchange arm |
| Traditional extraventricular drainThe retrospective analysis will be performed on the last 60 traditional external ventricular drains. | Device | Retrospective analysis of traditional external ventricular drains |
| Non-contrast head CTsNon-contrast head CTs will be performed at least every 48 hours to document effectiveness. This frequency is standard, if not more frequent as necessary, for patients with external ventricular drainage and intraventricular hemorrhage. Scans are routinely obtained at this frequency to evaluate, for example: evacuation of hemorrhage, admission pathology, post-placement of catheters, any change in neurological exam, or after elevations in intracranial pressure. With these common CT scans we will be able to assess the efficacy of the IRRAflow catheter on the specified parameters. These scans are routinely performed due to this pathology and as such are covered as a necessity of the hospitalization by the insurance companies. MRI may be used in place of a CT scan if medically indicated as determined by the neurosurgical attending or neurocritical care attending according to standard of care for treatment of the neurological pathology. | Procedure or surgery | IRRAflow with Active Fluid Exchange arm |
Primary outcome
Residual blood volume
Time frame: At day 5
Residual blood volume on post bleed day 5
4 secondary outcomes
Serious adverse events
Time frame: up to 48 hours post-procedure
Hospital quality metrics
Time frame: up to 48 hours post-procedure
Length of stay in the NSICU
Time frame: up to 48 hours post-procedure
Direct hospitalization costs
Time frame: up to 48 hours post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. In order to minimize any privacy risks to the patients participating, IPD data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher P Kellner, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRRAflow® Active Fluid Exchange System, Traditional extraventricular drain and Non-contrast head CTs in people with Intraventricular Hemorrhage (IVH), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Svendsen ((212) 241-3238, Emily.Svendsen@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual blood volume (time frame: At day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.