<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/NCT03249220</url>
  </required_header>
  <id_info>
    <org_study_id>2015.5703</org_study_id>
    <nct_id>NCT03249220</nct_id>
  </id_info>
  <brief_title>Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Patients</brief_title>
  <acronym>CBMS FIH</acronym>
  <official_title>Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device That Allows the Measurement of Regional Cerebral Blood Flow (rCBF), Intracranial Pressure (ICP), Brain Temperature Monitoring and Ventricular Cerebrospinal Fluid (CSF) Drainage in Brain-injured Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carag AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carag AG</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the&#xD;
      measurement of regional cerebral blood flow (rCBF), intracranial pressure (ICP), brain&#xD;
      temperature monitoring and ventricular cerebrospinal fluid (CSF) drainage in brain-injured&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Administrative reasons&#xD;
  </why_stopped>
  <start_date type="Actual">January 18, 2018</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD</measure>
    <time_frame>Up to 28 days until probe removal</time_frame>
    <description>Regional CBF values calculated with the investigational devices (CBMS) are within ranges described in literature, and dynamic changes of regional CBF are consistent to those values obtained with established methods CT perfusion and TCD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety related to catheter insertion and monitoring</measure>
    <time_frame>Until 7 days after probe removal</time_frame>
    <description>Safety related to catheter insertion and monitoring: local hematomas, infections, CSF drainage dysfunction in comparison with other standard intra-ventricular devices.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Brain Injuries</condition>
  <arm_group>
    <arm_group_label>CBMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placement of the CBMS Probe</intervention_name>
    <description>Patients will be treated according to standard care in place at the investigation site, when intra-ventricular drainage is needed. Patients will receive the new multifunctional device (CBMS Probe) instead of the single function device generally used. Drainage will be performed by routine standards. Temperature, intracranial pressure and cerebral blood flow will be recorded. Treatment decision will be made by the neurointensive care specialist based on standard care.</description>
    <arm_group_label>CBMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult male or female patient, aged 18 - 75 years&#xD;
&#xD;
          -  Brain injured patients with acute intracranial hemorrhage (including aneurysmal&#xD;
             subarachnoid hemorrhage (SAH) and spontaneous intracerebral hemorrhage (ICH)) who are&#xD;
             admitted to the ICU and have an indication for ICP monitoring and CSF drainage, as per&#xD;
             standard patient care&#xD;
&#xD;
          -  Informed consent obtained for research in emergency situations according to HRA art.&#xD;
             30 &amp; 31 at time of inclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known kidney disease, defined as plasma creatinine &gt; 120 μmol/l&#xD;
&#xD;
          -  Known liver disease, defined as AST &gt; 200 IU/L&#xD;
&#xD;
          -  Over-active thyroid or benign tumors of the thyroid&#xD;
&#xD;
          -  History of allergic disorders, including allergic reactions, against contrast agents&#xD;
             containing iodine, or against ICG&#xD;
&#xD;
          -  Patients which have received one of the following medications before being admitted to&#xD;
             ICU: Haloperidol, Meperidine, Methadone, Morphine, Phenobarbital and Rifamycin.&#xD;
&#xD;
          -  Patients with wounds or scars including the front orbital region.&#xD;
&#xD;
          -  Cerebrospinal fluid infection or signs of meningo-encephalitis&#xD;
&#xD;
          -  Anemia (hemoglobin &lt; 10 g/dl) or Thalassemia&#xD;
&#xD;
          -  Carbon monoxide poisoning&#xD;
&#xD;
          -  Acquired pathological or congenital disorders of the cerebral system, being clinically&#xD;
             significant, respectively interfering in the investigator's opinion with the conduct&#xD;
             of study&#xD;
&#xD;
          -  Documented history of bleeding, clotting or coagulation disorders&#xD;
&#xD;
          -  Patients who are not suitable for a CT perfusion&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, will be inappropriate for inclusion&#xD;
             into this clinical investigation or will not comply with requirements of the study&#xD;
&#xD;
          -  Any disorder in the investigator's opinion that could interfere with compliance of&#xD;
             safety evaluation&#xD;
&#xD;
          -  Pre-existing disability and/or legal representative&#xD;
&#xD;
          -  Patients who are kept lawfully in an institution&#xD;
&#xD;
          -  Participation in another interventional clinical investigation within the last 30 days&#xD;
             before start of treatment&#xD;
&#xD;
          -  History of, respectively diagnosis of pregnancy, or breastfeeding patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mauro Oddo, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Vaudoise CHUV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois CHUV</name>
      <address>
        <city>Lausanne</city>
        <state>VD</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03249220
org study id: 2015.5703
nct id: NCT03249220
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the
      measurement of regional cerebral blood flow (rCBF), intracranial pressure (ICP), brain
      temperature monitoring and ventricular cerebrospinal fluid (CSF) drainage in brain-injured
      patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD
time frame: Up to 28 days until probe removal
description: Regional CBF values calculated with the investigational devices (CBMS) are within ranges described in literature, and dynamic changes of regional CBF are consistent to those values obtained with established methods CT perfusion and TCD.
measure: Safety related to catheter insertion and monitoring
time frame: Until 7 days after probe removal
description: Safety related to catheter insertion and monitoring: local hematomas, infections, CSF drainage dysfunction in comparison with other standard intra-ventricular devices.
arm group label: CBMS
arm group type: Experimental
intervention type: Device
intervention name: Placement of the CBMS Probe
description: Patients will be treated according to standard care in place at the investigation site, when intra-ventricular drainage is needed. Patients will receive the new multifunctional device (CBMS Probe) instead of the single function device generally used. Drainage will be performed by routine standards. Temperature, intracranial pressure and cerebral blood flow will be recorded. Treatment decision will be made by the neurointensive care specialist based on standard care.
arm group label: CBMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mauro Oddo, Prof. Dr.
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Vaudoise CHUV
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Brain Injuries
sharing ipd: Undecided