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/NCT06038513</url>
    </required_header>
    <id_info>
      <org_study_id>COT-002</org_study_id>
      <nct_id>NCT06038513</nct_id>
    </id_info>
    <brief_title>Transnasal Induction of Normothermia for Neurogenic Fever</brief_title>
    <official_title>A Prospective, Open Label Clinical Trial to Evaluate the Safety and Efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in Inducing Normothermia for Neurogenic Fever in an Intensive Care Setting</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CoolTech LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Maryland Industrial Partnerships</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>CoolTech LLC</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>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal Thermal&#xD;
        Regulating Device in reducing temperature in a population of febrile subjects who meet the&#xD;
        inclusion/exclusion criteria.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">October 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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time to achieve normothermia (≤37.5°C)</measure>
      <time_frame>24 hours</time_frame>
      <description>To evaluate the efficacy of the COOLSTAT® in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period</measure>
      <time_frame>24 hours</time_frame>
      <description>To evaluate the efficacy of the COOLSTAT® in maintaining normothermia over a 24-hour cooling period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of shivering during cooling period</measure>
      <time_frame>24 hours</time_frame>
      <description>To assess the frequency of shivering incidents caused by the CoolStat device.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of shivering interventions per patient</measure>
      <time_frame>24 hours</time_frame>
      <description>To assess the frequency shivering interventions caused by the CoolStat device.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events.</measure>
      <time_frame>24 hours</time_frame>
      <description>To evaluate the safety of the CoolStat device.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Stroke, Ischemic</condition>
    <condition>Stroke Hemorrhagic</condition>
    <condition>Seizures</condition>
    <condition>Metabolic Encephalopathy</condition>
    <arm_group>
      <arm_group_label>Transnasal Thermal Regulating Device</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Consented subjects who develop fever will undergo cooling via transnasal thermal regulating device for a period of 24 hours</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transnasal Thermal Regulating Device</intervention_name>
      <description>Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 24 hours</description>
      <arm_group_label>Transnasal Thermal Regulating Device</arm_group_label>
      <other_name>CoolStat</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Admitted to an Intensive Care Unit for a planned stay of at least 24 hours with a&#xD;
               diagnosis of ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.&#xD;
  &#xD;
            2. Ages 18-85 years, inclusive.&#xD;
  &#xD;
            3. Patient has fever ≥ 38.3°C and ≤ 38.9°C at the time of treatment initiation.&#xD;
  &#xD;
            4. Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.&#xD;
  &#xD;
            5. Glasgow Coma Scale score of 3-11, inclusive.&#xD;
  &#xD;
            6. Must have informed consent from the patient or the legally authorized representative&#xD;
               (LAR) making decisions for the patient.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Intubation is contraindicated.&#xD;
  &#xD;
            2. Weight of ≤ 100lb or ≥ 250lb.&#xD;
  &#xD;
            3. Active/ongoing epistaxis.&#xD;
  &#xD;
            4. Known or suspected pregnancy.&#xD;
  &#xD;
            5. Participation in another ongoing investigational study.&#xD;
  &#xD;
            6. Prisoners and/or patients for whom no LAR is available.&#xD;
  &#xD;
            7. Patient is in airborne/droplet disease isolation protocol.&#xD;
  &#xD;
            8. Patient is or suspected to be immunocompromised.&#xD;
  &#xD;
            9. Nasal septal deviations (per standard of care CT scan; any degree).&#xD;
  &#xD;
           10. Chronic rhinosinusitis.&#xD;
  &#xD;
           11. Traumatic brain injury.&#xD;
  &#xD;
           12. Prior skull-base surgery.&#xD;
  &#xD;
           13. Penetrating cranial trauma.&#xD;
  &#xD;
           14. Recent nasal trauma or anterior base skull fracture.&#xD;
  &#xD;
           15. Any condition for which transnasal air flow would be contraindicated.&#xD;
  &#xD;
           16. Refractory hypoxemia (partial pressure of oxygen in arterial blood (paO2) below 60&#xD;
               torr or oxyhemoglobin saturation below 90% despite endotracheal intubation, mechanical&#xD;
               ventilation, and provision of supplemental oxygen of up to 0.60).&#xD;
  &#xD;
           17. Refractory hypercarbia (partial pressure of carbon dioxide in arterial blood (paCO2)&#xD;
               above 50 torr despite endotracheal intubation and conventional mechanical&#xD;
               ventilation).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Casey Hannan, BSc</last_name>
      <phone>203-685-6352</phone>
      <email>channan@cooltechcorp.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Maryland Medical Center</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21201</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>David Peprah</last_name>
        <email>dpeprah@som.umaryland.edu</email>
      </contact>
      <investigator>
        <last_name>Neeraj Badjatia, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>shivering, fever, normothermia, TTM</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Seizures</mesh_term>
      <mesh_term>Brain Diseases</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Hemorrhagic Stroke</mesh_term>
      <mesh_term>Brain Diseases, Metabolic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06038513
  org study id: COT-002
  nct id: NCT06038513
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal Thermal
        Regulating Device in reducing temperature in a population of febrile subjects who meet the
        inclusion/exclusion criteria.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Time to achieve normothermia (≤37.5°C)
  time frame: 24 hours
  description: To evaluate the efficacy of the COOLSTAT® in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.
  measure: Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period
  time frame: 24 hours
  description: To evaluate the efficacy of the COOLSTAT® in maintaining normothermia over a 24-hour cooling period
  measure: Incidence of shivering during cooling period
  time frame: 24 hours
  description: To assess the frequency of shivering incidents caused by the CoolStat device.
  measure: Number of shivering interventions per patient
  time frame: 24 hours
  description: To assess the frequency shivering interventions caused by the CoolStat device.
  measure: Incidence of adverse events.
  time frame: 24 hours
  description: To evaluate the safety of the CoolStat device.
  arm group label: Transnasal Thermal Regulating Device
  arm group type: Experimental
  description: Consented subjects who develop fever will undergo cooling via transnasal thermal regulating device for a period of 24 hours
  intervention type: Device
  intervention name: Transnasal Thermal Regulating Device
  description: Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 24 hours
  arm group label: Transnasal Thermal Regulating Device
  other name: CoolStat
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Casey Hannan, BSc
  phone: 203-685-6352
  email: channan@cooltechcorp.com
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Seizures
  mesh term: Brain Diseases
  mesh term: Ischemic Stroke
  mesh term: Hemorrhagic Stroke
  mesh term: Brain Diseases, Metabolic
  sharing ipd: No