xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05970549</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY-21-01815</org_study_id>
      <nct_id>NCT05970549</nct_id>
    </id_info>
    <brief_title>Intraventricular Catheter System for IVH</brief_title>
    <acronym>DIVE</acronym>
    <official_title>DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Icahn School of Medicine at Mount Sinai</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>IRRAS</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Icahn School of Medicine at Mount Sinai</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this research study is to evaluate the safety and outcomes associated with the&#xD;
        use of IRRAflow® System catheters in externally draining intracranial fluid to reduce&#xD;
        intracranial pressure. This study will be comparing the IRRAflow® system to standard of care&#xD;
        catheters used in the same procedure. The IRRAflow® system is FDA approved for this&#xD;
        procedure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Intracranial hemorrhagic conditions can rapidly cause brain damage and often considered life-&#xD;
        threatening. Of these, Intracerebral hemorrhagic (ICH) is the most common type of hemorrhagic&#xD;
        stroke and is associated with higher rates of morbidity and mortality than all stroke&#xD;
        subtypes.&#xD;
  &#xD;
        Management of hemorrhagic patients is typically orchestrated by neurosurgeons and&#xD;
        neuro-intensivists. Comprehensive care should include surveillance and monitoring of Intra&#xD;
        Cranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and hemodynamic function.&#xD;
        Furthermore, prevention of infection, complications of immobility through positioning and&#xD;
        mobilization within physiological tolerance play an important role in optimizing outcomes&#xD;
        after ICH.&#xD;
  &#xD;
        There are multiple approaches to facilitating Cerebrospinal Fluid (CSF) drainage and monitor&#xD;
        ICP. Routinely, intracranial pressure is measured by use of devices inserted into the brain&#xD;
        parenchyma or cerebral ventricles. A Ventricular Catheter (VC) inserted into the lateral&#xD;
        ventricle allows for drainage of CSF to help reduce ICP. Although CSF drainage is a vital&#xD;
        sequence in patient management, there are reported risks including infection and limitations&#xD;
        related to erroneous readings associated with current ICP monitors. Physicians lack the&#xD;
        appropriate tools to employ active intermittent aspiration and drainage with continuous ICP&#xD;
        monitoring.&#xD;
  &#xD;
        The current clinical study is being initiated to evaluate the hypothesis that active&#xD;
        irrigation by IRRAflow will reduce the time needed for clearance of intraventricular blood&#xD;
        from intraventricular space.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 14, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>There will be no masking involved. The proposed study is a single center retrospective and prospective cohort, controlled, single-center, phase 1 study evaluating the safety and radiographic outcomes associated use of the IRRAS catheter compared to standard of care external ventricular drains.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Residual blood volume</measure>
      <time_frame>At day 5</time_frame>
      <description>Residual blood volume on post bleed day 5</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Serious adverse events</measure>
      <time_frame>up to 48 hours post-procedure</time_frame>
      <description>Number of serious adverse events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital quality metrics</measure>
      <time_frame>up to 48 hours post-procedure</time_frame>
      <description>Length of stay in the NSICU as a quality metrics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of stay in the NSICU</measure>
      <time_frame>up to 48 hours post-procedure</time_frame>
      <description>Length of hospital stay in the as a quality metrics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Direct hospitalization costs</measure>
      <time_frame>up to 48 hours post-procedure</time_frame>
      <description>Direct hospitalization costs</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Intraventricular Hemorrhage (IVH)</condition>
    <arm_group>
      <arm_group_label>IRRAflow with Active Fluid Exchange arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Retrospective analysis of traditional external ventricular drains</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The retrospective analysis will be performed on the last 60 traditional external ventricular drains.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>IRRAflow® Active Fluid Exchange System</intervention_name>
      <description>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.&#xD;
  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.</description>
      <arm_group_label>IRRAflow with Active Fluid Exchange arm</arm_group_label>
      <other_name>IRRAflow® CNS System</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Traditional extraventricular drain</intervention_name>
      <description>The retrospective analysis will be performed on the last 60 traditional external ventricular drains.</description>
      <arm_group_label>Retrospective analysis of traditional external ventricular drains</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Non-contrast head CTs</intervention_name>
      <description>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.</description>
      <arm_group_label>IRRAflow with Active Fluid Exchange arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;=18 years of age&#xD;
  &#xD;
            -  Intraventricular hemorrhage documented on head CT or MRI scan&#xD;
  &#xD;
            -  Need of cerebrospinal fluid drainage&#xD;
  &#xD;
            -  Indication for active treatment evaluated by the treating physicians&#xD;
  &#xD;
            -  Signed informed consent obtained by patient or Legal Authorized Representative&#xD;
  &#xD;
            -  Treatment possible within 72 hours of ictus&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient has fixed and dilated pupils&#xD;
  &#xD;
            -  Pregnant or nursing women (fertile female participants will be required to take a&#xD;
               validated pregnancy test for evaluation of pregnancy)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christopher P Kellner, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Christopher P Kellner, MD</last_name>
      <phone>212-241-2606</phone>
      <email>christopher.kellner@mountsinai.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Trevor Hardigan, MD PhD</last_name>
      <phone>212-241-2606</phone>
      <email>trevor.hardigan@mountsinai.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Icahn School of Medicine at Mount Sinai</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10128</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Christopher P Kellner, MD</last_name>
        <phone>212-241-2606</phone>
        <email>christopher.kellner@mountsinai.org</email>
      </contact>
      <contact_backup>
        <last_name>Trevor Hardigan, MD PhD</last_name>
        <phone>212-241-2606</phone>
        <email>trevor.hardigan@mountsinai.org</email>
      </contact_backup>
      <investigator>
        <last_name>Christopher P Kellner</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 3, 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
      <investigator_full_name>Christopher P Kellner</investigator_full_name>
      <investigator_title>Assistant Professor in Neurosurgery</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cerebral Hemorrhage</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>In order to minimize any privacy risks to the patients participating, IPD data will not be shared.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05970549
  org study id: STUDY-21-01815
  nct id: NCT05970549
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  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.
  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.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  intervention 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.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: There will be no masking involved. The proposed study is a single center retrospective and prospective cohort, controlled, single-center, phase 1 study evaluating the safety and radiographic outcomes associated use of the IRRAS catheter compared to standard of care external ventricular drains.
  measure: Residual blood volume
  time frame: At day 5
  description: Residual blood volume on post bleed day 5
  measure: Serious adverse events
  time frame: up to 48 hours post-procedure
  description: Number of serious adverse events
  measure: Hospital quality metrics
  time frame: up to 48 hours post-procedure
  description: Length of stay in the NSICU as a quality metrics
  measure: Length of stay in the NSICU
  time frame: up to 48 hours post-procedure
  description: Length of hospital stay in the as a quality metrics
  measure: Direct hospitalization costs
  time frame: up to 48 hours post-procedure
  description: Direct hospitalization costs
  arm group label: IRRAflow with Active Fluid Exchange arm
  arm group type: Experimental
  description: The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria.
  arm group label: Retrospective analysis of traditional external ventricular drains
  arm group type: Active Comparator
  description: The retrospective analysis will be performed on the last 60 traditional external ventricular drains.
  intervention type: Device
  intervention name: IRRAflow® Active Fluid Exchange System
  description: 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.
  arm group label: IRRAflow with Active Fluid Exchange arm
  other name: IRRAflow® CNS System
  intervention type: Device
  intervention name: Traditional extraventricular drain
  description: The retrospective analysis will be performed on the last 60 traditional external ventricular drains.
  arm group label: Retrospective analysis of traditional external ventricular drains
  intervention type: Procedure
  intervention name: Non-contrast head CTs
  description: 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.
  arm group label: IRRAflow with Active Fluid Exchange arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Christopher P Kellner, MD
  role: Principal Investigator
  affiliation: Icahn School of Medicine at Mount Sinai
  last name: Christopher P Kellner, MD
  phone: 212-241-2606
  email: christopher.kellner@mountsinai.org
  last name: Trevor Hardigan, MD PhD
  phone: 212-241-2606
  email: trevor.hardigan@mountsinai.org
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Icahn School of Medicine at Mount Sinai
  investigator full name: Christopher P Kellner
  investigator title: Assistant Professor in Neurosurgery
  mesh term: Cerebral Hemorrhage
  mesh term: Hemorrhage
  sharing ipd: No
  ipd description: In order to minimize any privacy risks to the patients participating, IPD data will not be shared.