<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/NCT02226614</url>
  </required_header>
  <id_info>
    <org_study_id>vs1 25.03.14</org_study_id>
    <nct_id>NCT02226614</nct_id>
  </id_info>
  <brief_title>Development of a Head Cooling Device</brief_title>
  <official_title>Development of a Head-cooling Device for Brain Injury: Healthy Volunteer Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Edinburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is testing a head-cooling device on volunteers to assess temperature reduction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Temperature change</measure>
    <time_frame>6 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Body Temperature Changes</condition>
  <arm_group>
    <arm_group_label>head cooling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>head cooling</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>University of Edinburgh head cooling device</intervention_name>
    <description>head cooling</description>
    <arm_group_label>head cooling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy humans&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  refusal of consent for registration with The Over-volunteering Protection Scheme&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Andrews, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Edinburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Western General Hospital</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>June 14, 2016</last_update_submitted>
  <last_update_submitted_qc>June 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 15, 2016</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>Body Temperature Changes</mesh_term>
  </condition_browse>
  <!-- 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/NCT02226614
org study id: vs1 25.03.14
nct id: NCT02226614
lead sponsor: 
has dmc: No
This study is testing a head-cooling device on volunteers to assess temperature reduction.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Temperature change
time frame: 6 hours
arm group label: head cooling
arm group type: Experimental
description: head cooling
intervention type: Device
intervention name: University of Edinburgh head cooling device
description: head cooling
arm group label: head cooling
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Andrews, MD
role: Principal Investigator
affiliation: University of Edinburgh
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Body Temperature Changes