<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/NCT03797300</url>
  </required_header>
  <id_info>
    <org_study_id>SpryUCSF2</org_study_id>
    <nct_id>NCT03797300</nct_id>
  </id_info>
  <brief_title>Pulse Oximeter and Respiratory Rate Test</brief_title>
  <official_title>Accuracy of Pulse Oximeters With Profound Hypoxia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spry Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Spry Health</source>
  <oversight_info>
    <has_dmc>No</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia Assessment of Spry&#xD;
      Health's Respiratory rate accuracy in normal conditions and profound hypoxia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">December 14, 2018</completion_date>
  <primary_completion_date type="Actual">December 14, 2018</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of SpO2 measurement</measure>
    <time_frame>duration of subject monitoring, usually up to one hour</time_frame>
    <description>Pulse oximetry measurement accuracy vs. gold standard</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy of Respiratory Rate measurement</measure>
    <time_frame>duration of subject monitoring, usually up to one hour</time_frame>
    <description>Respiratory rate measurement accuracy vs. gold standard</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Hypoxia</condition>
  <condition>Hypercapnia</condition>
  <condition>Hypocapnia</condition>
  <arm_group>
    <arm_group_label>Primary</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spry Loop Band</intervention_name>
    <description>Loop band measures pulse oximetry and respiration rate</description>
    <arm_group_label>Primary</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult willing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Wrist size outside the indicated use&#xD;
&#xD;
          -  Low perfusion&#xD;
&#xD;
          -  Smoking&#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>
  <location>
    <facility>
      <name>UCSF Hypoxia Lab</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</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>Hypoxia</mesh_term>
    <mesh_term>Hypercapnia</mesh_term>
    <mesh_term>Hypocapnia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03797300
org study id: SpryUCSF2
nct id: NCT03797300
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia Assessment of Spry
      Health's Respiratory rate accuracy in normal conditions and profound hypoxia
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Accuracy of SpO2 measurement
time frame: duration of subject monitoring, usually up to one hour
description: Pulse oximetry measurement accuracy vs. gold standard
measure: Accuracy of Respiratory Rate measurement
time frame: duration of subject monitoring, usually up to one hour
description: Respiratory rate measurement accuracy vs. gold standard
arm group label: Primary
arm group type: Experimental
intervention type: Device
intervention name: Spry Loop Band
description: Loop band measures pulse oximetry and respiration rate
arm group label: Primary
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypoxia
mesh term: Hypercapnia
mesh term: Hypocapnia
sharing ipd: No