<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/NCT03750344</url>
  </required_header>
  <id_info>
    <org_study_id>PR 2018-305</org_study_id>
    <nct_id>NCT03750344</nct_id>
  </id_info>
  <brief_title>ChroniSense Polso Wrist Worn Respiration Rate Validation Study</brief_title>
  <official_title>ChroniSense Polso Wrist Worn Respiration Rate Validation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ChroniSense Medical Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ChroniSense Medical Ltd.</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>
      20 volunteer test subjects will be entered into an accuracy study that is designed to&#xD;
      validate accuracy of the respiratory rate of the Polso Monitoring system&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      20 volunteer test subjects will be entered into an accuracy study that is designed to&#xD;
      validate accuracy of the respiratory rate of the Polso Monitoring system.&#xD;
&#xD;
      A range of stable respiratory rates will be elicited from each volunteer test subject. The&#xD;
      rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute; with&#xD;
      some natural variation from these exact numbers.&#xD;
&#xD;
      Each subject will be instrumented with an open system mask that allows for measurement of the&#xD;
      end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor will be&#xD;
      used as the Accuracy Reference Device (Reference) in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2018</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 9, 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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory Rate Accuracy of Polso Monitoring System</measure>
    <time_frame>Through study completion, 1 month average</time_frame>
    <description>Respiratory Rate of test subject as compared to CO2 of End Tidal Carbon. Twenty second periods will be averaged to provide one respiratory rate value. Each stable respiratory rate plateau will result in four of these respiratory rate values which will be included in the ARMS calculation. The endpoint of interest is accuracy as measured by the Accuracy root-mean-square (Arms) difference between the device under test (DUT) and the reference respiratory rate system (Ref) for all stable respiratory periods. Acceptance criteria ARMS &lt;3</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Respiratory Rate</condition>
  <arm_group>
    <arm_group_label>ChroniSense Polso Respiratory Rate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Diagnostic test</intervention_name>
    <description>Comparison of respiratory rates in normal subjects as observational with end tidal CO2. No treatment or interventions will be performed</description>
    <arm_group_label>ChroniSense Polso Respiratory Rate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must have the ability to understand and provide written informed consent&#xD;
&#xD;
          -  Subject is adult over 18 years of age&#xD;
&#xD;
          -  Subject must be willing and able to comply with study procedures and duration&#xD;
&#xD;
          -  Subject is a non-smoker&#xD;
&#xD;
          -  Male or female of any race&#xD;
&#xD;
          -  Wrist circumference with the range of 5.5-8 inches (13 to 21cm)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is considered as being morbidly obese (defined as BMI &gt;39.5)&#xD;
&#xD;
          -  Compromised circulation, injury, or physical malformation of fingers, toes, hands,&#xD;
             ears or forehead/skull or other sensor sites which would limit the ability to test&#xD;
             sites needed for the study. Tattoo in the optical path which would limit the ability&#xD;
             to test sites needed for the study.&#xD;
&#xD;
          -  Subjects with known respiratory conditions such as:&#xD;
&#xD;
               -  uncontrolled / severe asthma,&#xD;
&#xD;
               -  flu,&#xD;
&#xD;
               -  pneumonia / bronchitis,&#xD;
&#xD;
               -  shortness of breath / respiratory distress,&#xD;
&#xD;
               -  respiratory or lung surgery,&#xD;
&#xD;
               -  emphysema, COPD, lung disease&#xD;
&#xD;
          -  Subjects with self-reported heart or cardiovascular conditions such as:&#xD;
&#xD;
               -  have had cardiovascular surgery&#xD;
&#xD;
               -  Chest pain (angina)&#xD;
&#xD;
               -  heart rhythms other than a normal sinus rhythm or with respiratory sinus&#xD;
                  arrhythmia&#xD;
&#xD;
               -  previous heart attack&#xD;
&#xD;
               -  blocked artery&#xD;
&#xD;
               -  unexplained shortness of breath&#xD;
&#xD;
               -  congestive heart failure (CHF)&#xD;
&#xD;
               -  history of stroke&#xD;
&#xD;
               -  transient ischemic attack&#xD;
&#xD;
               -  carotid artery disease&#xD;
&#xD;
               -  myocardial ischemia&#xD;
&#xD;
               -  myocardial infarction&#xD;
&#xD;
               -  cardiomyopathy&#xD;
&#xD;
          -  Self-reported health conditions as identified in the Health Assessment Form&#xD;
&#xD;
               -  diabetes,&#xD;
&#xD;
               -  uncontrolled thyroid disease,&#xD;
&#xD;
               -  kidney disease / chronic renal impairment,&#xD;
&#xD;
               -  history of seizures (except childhood febrile seizures),&#xD;
&#xD;
               -  epilepsy,&#xD;
&#xD;
               -  history of unexplained syncope,&#xD;
&#xD;
               -  recent history of frequent migraine headaches,&#xD;
&#xD;
               -  recent head injury within the last 2 months,&#xD;
&#xD;
          -  Cancer / chemotherapy&#xD;
&#xD;
          -  Other known health condition should be considered upon disclosure in health assessment&#xD;
             form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arthur D Cabrera, MD</last_name>
    <role>Study Director</role>
    <affiliation>Avista Adventist Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinimark</name>
      <address>
        <city>Louisville</city>
        <state>Colorado</state>
        <zip>80027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Respiratory Rate</keyword>
  <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/NCT03750344
org study id: PR 2018-305
nct id: NCT03750344
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
20 volunteer test subjects will be entered into an accuracy study that is designed to
      validate accuracy of the respiratory rate of the Polso Monitoring system
20 volunteer test subjects will be entered into an accuracy study that is designed to
      validate accuracy of the respiratory rate of the Polso Monitoring system.

      A range of stable respiratory rates will be elicited from each volunteer test subject. The
      rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute; with
      some natural variation from these exact numbers.

      Each subject will be instrumented with an open system mask that allows for measurement of the
      end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor will be
      used as the Accuracy Reference Device (Reference) in this study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Respiratory Rate Accuracy of Polso Monitoring System
time frame: Through study completion, 1 month average
description: Respiratory Rate of test subject as compared to CO2 of End Tidal Carbon. Twenty second periods will be averaged to provide one respiratory rate value. Each stable respiratory rate plateau will result in four of these respiratory rate values which will be included in the ARMS calculation. The endpoint of interest is accuracy as measured by the Accuracy root-mean-square (Arms) difference between the device under test (DUT) and the reference respiratory rate system (Ref) for all stable respiratory periods. Acceptance criteria ARMS <3
arm group label: ChroniSense Polso Respiratory Rate
arm group type: Experimental
intervention type: Device
intervention name: Diagnostic test
description: Comparison of respiratory rates in normal subjects as observational with end tidal CO2. No treatment or interventions will be performed
arm group label: ChroniSense Polso Respiratory Rate
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Arthur D Cabrera, MD
role: Study Director
affiliation: Avista Adventist Hospital
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No