<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/NCT03835260</url>
  </required_header>
  <id_info>
    <org_study_id>C-404</org_study_id>
    <nct_id>NCT03835260</nct_id>
  </id_info>
  <brief_title>Pivot Breath Sensor Human Factors and Usability Study</brief_title>
  <official_title>Pivot Breath Sensor Human Factors and Usability Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jennifer Marler, MD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UserWise, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Pivot Health Technologies Inc.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, observational open label, single center study enrolling up to 15 subjects to&#xD;
      evaluate human factors and usability of the Pivot Breath Sensor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this Human Factors/Usability study are to:&#xD;
&#xD;
        -  Ensure that representative intended users are able to operate the Pivot Breath Sensor&#xD;
           independently&#xD;
&#xD;
        -  Validate appropriate mitigations of use related hazards identified in risk management&#xD;
           documentation&#xD;
&#xD;
        -  Uncover previously unforeseen use errors&#xD;
&#xD;
      This human factors and usability testing is conducted to demonstrate that the Pivot Breath&#xD;
      Sensor can be used by the intended users without serious use errors or problems, for the&#xD;
      intended uses and under the expected use conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Actual">April 18, 2019</completion_date>
  <primary_completion_date type="Actual">April 18, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings</measure>
    <time_frame>Each study session was completed on a single day, for up to 60 minutes. Device set up was assessed at about 5 minutes in. Device use was assessed at about 10 minutes in. Interpretation of results was assessed at about 15 and 20 minutes in.</time_frame>
    <description>User performance of participants in intended use scenarios will be assessed at a single visit. Participants will be observed if they can set up the device, use the device, and interpret results. Observer ratings include 'Successful' and 'Unsuccessful'. Specific attention will be given to assess if any harms can occur from observed use errors.&#xD;
'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively.&#xD;
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.&#xD;
Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute and assessments will be made over the study session which can last up to 60 minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Human Factors - User Documentation Assessment With Observer Ratings</measure>
    <time_frame>Each study session was completed on a single day, for up to 60 minutes. The user documentation assessment occurred at approximately 30 minutes into the study session.</time_frame>
    <description>Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide and user manual. Observer ratings include 'Successful' and 'Unsuccessful'.&#xD;
'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively.&#xD;
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.&#xD;
Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute each. The User documentation assessment portion of the study session will last up to 30 minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Human Factors - Subjective Feedback Questionnaire</measure>
    <time_frame>Each study session was completed on a single day, for up to 60 minutes. The subjective feedback questionnaire was administered at approximately 40 minutes into the study session.</time_frame>
    <description>Subjective feedback focusing on any concerns on using device will be assessed at single visit. Participants will answer with a Yes or No to the questions.&#xD;
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.&#xD;
Subjective feedback focusing on any concerns prior to the conclusion of the study session. Subjective feedback questions will take approximately 1-3 minutes each. The Subjective feedback portion of the study session will last up to 5 to 15 minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Human Factors - Participant Feedback Using Rating Scale</measure>
    <time_frame>Each study session was completed on a single day, for up to 60 minutes. Participant feedback using a rating scale was provided at approximately 50 minutes into the study session.</time_frame>
    <description>Participant will be asked to provide ratings on the following:&#xD;
How would you rate the ease or difficulty using the device?&#xD;
How clear or unclear was the Quick Start Guide?&#xD;
How clear or unclear was the Packaging?&#xD;
How clear or unclear was the User Manual?&#xD;
How easy or difficult was it to understand and interpret the test results?&#xD;
The participant will use the following rating scale (higher score = better outcome):&#xD;
5 - Very Easy 4 - Easy 3 - Neither Easy nor Difficult 2 - Difficult&#xD;
1 - Very difficult&#xD;
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.&#xD;
Participant will provide the ratings prior to the conclusion of the study session. Participant assessment with questionnaire rating scales will take approximately 1-2 minutes each.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Smoking, Tobacco</condition>
  <arm_group>
    <arm_group_label>Pivot Breath Sensor (user group)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Self-reported daily smokers of 2 or more cigarettes per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pivot Breath Sensor</intervention_name>
    <description>The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.</description>
    <arm_group_label>Pivot Breath Sensor (user group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-80 years of age&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Owns and uses a smartphone&#xD;
&#xD;
          -  Willing to sign the Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior experience with a study sponsored by Carrot Inc&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Marler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pivot Health Technologies Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carrot Inc.</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <results_first_submitted>September 15, 2022</results_first_submitted>
  <results_first_submitted_qc>October 13, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 8, 2022</results_first_posted>
  <last_update_submitted>October 13, 2022</last_update_submitted>
  <last_update_submitted_qc>October 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Pivot Health Technologies Inc.</investigator_affiliation>
    <investigator_full_name>Jennifer Marler, MD</investigator_full_name>
    <investigator_title>Senior Director, Clinical and Medical Affairs</investigator_title>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT03835260/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pivot Breath Sensor (User Group)</title>
          <description>Self-reported daily smokers of 2 or more cigarettes per day&#xD;
Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pivot Breath Sensor (User Group)</title>
          <description>Self-reported daily smokers of 2 or more cigarettes per day&#xD;
Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age</title>
              <category_list>
                <category>
                  <title>Age 18-49 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Age 49-50 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <category_list>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Middle Eastern</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Daily Smoking Frequency (cigarettes per day)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>2-5 cpd</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6-10 cpd</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>11-15 cpd</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>16+ cpd</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings</title>
        <description>User performance of participants in intended use scenarios will be assessed at a single visit. Participants will be observed if they can set up the device, use the device, and interpret results. Observer ratings include 'Successful' and 'Unsuccessful'. Specific attention will be given to assess if any harms can occur from observed use errors.&#xD;
'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively.&#xD;
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.&#xD;
Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute and assessments will be made over the study session which can last up to 60 minutes.</description>
        <time_frame>Each study session was completed on a single day, for up to 60 minutes. Device set up was assessed at about 5 minutes in. Device use was assessed at about 10 minutes in. Interpretation of results was assessed at about 15 and 20 minutes in.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pivot Breath Sensor (User Group)</title>
            <description>Self-reported daily smokers of 2 or more cigarettes per day&#xD;
Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.</description>
          </group>
        </group_list>
        <measure>
          <title>Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings</title>
          <description>User performance of participants in intended use scenarios will be assessed at a single visit. Participants will be observed if they can set up the device, use the device, and interpret results. Observer ratings include 'Successful' and 'Unsuccessful'. Specific attention will be given to assess if any harms can occur from observed use errors.&#xD;
'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively.&#xD;
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.&#xD;
Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute and assessments will be made over the study session which can last up to 60 minutes.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Set up device - open packaging</title>
              <category_list>
                <category>
                  <title>Successful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unsuccessful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Use device</title>
              <category_list>
                <category>
                  <title>Successful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unsuccessful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interpret results</title>
              <category_list>
                <category>
                  <title>Successful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unsuccessful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Human Factors - User Documentation Assessment With Observer Ratings</title>
        <description>Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide and user manual. Observer ratings include 'Successful' and 'Unsuccessful'.&#xD;
'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively.&#xD;
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.&#xD;
Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute each. The User documentation assessment portion of the study session will last up to 30 minutes.</description>
        <time_frame>Each study session was completed on a single day, for up to 60 minutes. The user documentation assessment occurred at approximately 30 minutes into the study session.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pivot Breath Sensor (User Group)</title>
            <description>Self-reported daily smokers of 2 or more cigarettes per day&#xD;
Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.</description>
          </group>
        </group_list>
        <measure>
          <title>Human Factors - User Documentation Assessment With Observer Ratings</title>
          <description>Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide and user manual. Observer ratings include 'Successful' and 'Unsuccessful'.&#xD;
'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively.&#xD;
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.&#xD;
Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute each. The User documentation assessment portion of the study session will last up to 30 minutes.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>understanding of the packaging</title>
              <category_list>
                <category>
                  <title>Successful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unsuccessful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>understanding of the quick start guide</title>
              <category_list>
                <category>
                  <title>Successful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unsuccessful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>understanding of the user manual</title>
              <category_list>
                <category>
                  <title>Successful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unsuccessful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Human Factors - Subjective Feedback Questionnaire</title>
        <description>Subjective feedback focusing on any concerns on using device will be assessed at single visit. Participants will answer with a Yes or No to the questions.&#xD;
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.&#xD;
Subjective feedback focusing on any concerns prior to the conclusion of the study session. Subjective feedback questions will take approximately 1-3 minutes each. The Subjective feedback portion of the study session will last up to 5 to 15 minutes.</description>
        <time_frame>Each study session was completed on a single day, for up to 60 minutes. The subjective feedback questionnaire was administered at approximately 40 minutes into the study session.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pivot Breath Sensor (User Group)</title>
            <description>Self-reported daily smokers of 2 or more cigarettes per day&#xD;
Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.</description>
          </group>
        </group_list>
        <measure>
          <title>Human Factors - Subjective Feedback Questionnaire</title>
          <description>Subjective feedback focusing on any concerns on using device will be assessed at single visit. Participants will answer with a Yes or No to the questions.&#xD;
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.&#xD;
Subjective feedback focusing on any concerns prior to the conclusion of the study session. Subjective feedback questions will take approximately 1-3 minutes each. The Subjective feedback portion of the study session will last up to 5 to 15 minutes.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dd you experience any moments of hesitation while using the product?</title>
              <category_list>
                <category>
                  <title>yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>no</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you have any safety concerns regarding this product or its labeling?</title>
              <category_list>
                <category>
                  <title>yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>no</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Human Factors - Participant Feedback Using Rating Scale</title>
        <description>Participant will be asked to provide ratings on the following:&#xD;
How would you rate the ease or difficulty using the device?&#xD;
How clear or unclear was the Quick Start Guide?&#xD;
How clear or unclear was the Packaging?&#xD;
How clear or unclear was the User Manual?&#xD;
How easy or difficult was it to understand and interpret the test results?&#xD;
The participant will use the following rating scale (higher score = better outcome):&#xD;
5 - Very Easy 4 - Easy 3 - Neither Easy nor Difficult 2 - Difficult&#xD;
1 - Very difficult&#xD;
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.&#xD;
Participant will provide the ratings prior to the conclusion of the study session. Participant assessment with questionnaire rating scales will take approximately 1-2 minutes each.</description>
        <time_frame>Each study session was completed on a single day, for up to 60 minutes. Participant feedback using a rating scale was provided at approximately 50 minutes into the study session.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pivot Breath Sensor (User Group)</title>
            <description>Self-reported daily smokers of 2 or more cigarettes per day&#xD;
Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.</description>
          </group>
        </group_list>
        <measure>
          <title>Human Factors - Participant Feedback Using Rating Scale</title>
          <description>Participant will be asked to provide ratings on the following:&#xD;
How would you rate the ease or difficulty using the device?&#xD;
How clear or unclear was the Quick Start Guide?&#xD;
How clear or unclear was the Packaging?&#xD;
How clear or unclear was the User Manual?&#xD;
How easy or difficult was it to understand and interpret the test results?&#xD;
The participant will use the following rating scale (higher score = better outcome):&#xD;
5 - Very Easy 4 - Easy 3 - Neither Easy nor Difficult 2 - Difficult&#xD;
1 - Very difficult&#xD;
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.&#xD;
Participant will provide the ratings prior to the conclusion of the study session. Participant assessment with questionnaire rating scales will take approximately 1-2 minutes each.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>How would you rate the ease or difficulty of using the device?</title>
              <category_list>
                <category>
                  <title>very easy/very clear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>easy/clear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neither easy/clear nor difficult/unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>difficult/unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very difficult/very unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How clear or unclear was the Quick Start Guide?</title>
              <category_list>
                <category>
                  <title>very easy/very clear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>easy/clear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neither easy/clear nor difficult/unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>difficult/unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very difficult/very unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How clear or unclear was the packaging?</title>
              <category_list>
                <category>
                  <title>very easy/very clear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>easy/clear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neither easy/clear nor difficult/unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>difficult/unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very difficult/very unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How clear or unclear was the User Manual on the iPad?</title>
              <category_list>
                <category>
                  <title>very easy/very clear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>easy/clear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neither easy/clear nor difficult/unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>difficult/unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very difficult/very unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How easy or difficult was it to understand and interpret the test results?</title>
              <category_list>
                <category>
                  <title>very easy/very clear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>easy/clear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>neither easy/clear nor difficult/unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>difficult/unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>very difficult/very unclear</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were observed for throughout the entirety of each participant's study session, up to 60 minutes during a session on one day.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pivot Breath Sensor (User Group)</title>
          <description>Self-reported daily smokers of 2 or more cigarettes per day&#xD;
Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Director of Clinical Affairs and Data Science</name_or_title>
      <organization>Pivot Health Technologies Inc.</organization>
      <phone>650-906-4255</phone>
      <email>craig@pivot.co</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03835260
org study id: C-404
nct id: NCT03835260
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Prospective, observational open label, single center study enrolling up to 15 subjects to
      evaluate human factors and usability of the Pivot Breath Sensor.
The objectives of this Human Factors/Usability study are to:

        -  Ensure that representative intended users are able to operate the Pivot Breath Sensor
           independently

        -  Validate appropriate mitigations of use related hazards identified in risk management
           documentation

        -  Uncover previously unforeseen use errors

      This human factors and usability testing is conducted to demonstrate that the Pivot Breath
      Sensor can be used by the intended users without serious use errors or problems, for the
      intended uses and under the expected use conditions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings
time frame: Each study session was completed on a single day, for up to 60 minutes. Device set up was assessed at about 5 minutes in. Device use was assessed at about 10 minutes in. Interpretation of results was assessed at about 15 and 20 minutes in.
description: User performance of participants in intended use scenarios will be assessed at a single visit. Participants will be observed if they can set up the device, use the device, and interpret results. Observer ratings include 'Successful' and 'Unsuccessful'. Specific attention will be given to assess if any harms can occur from observed use errors.
'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively.
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.
Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute and assessments will be made over the study session which can last up to 60 minutes.
measure: Human Factors - User Documentation Assessment With Observer Ratings
time frame: Each study session was completed on a single day, for up to 60 minutes. The user documentation assessment occurred at approximately 30 minutes into the study session.
description: Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide and user manual. Observer ratings include 'Successful' and 'Unsuccessful'.
'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively.
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.
Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute each. The User documentation assessment portion of the study session will last up to 30 minutes.
measure: Human Factors - Subjective Feedback Questionnaire
time frame: Each study session was completed on a single day, for up to 60 minutes. The subjective feedback questionnaire was administered at approximately 40 minutes into the study session.
description: Subjective feedback focusing on any concerns on using device will be assessed at single visit. Participants will answer with a Yes or No to the questions.
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.
Subjective feedback focusing on any concerns prior to the conclusion of the study session. Subjective feedback questions will take approximately 1-3 minutes each. The Subjective feedback portion of the study session will last up to 5 to 15 minutes.
measure: Human Factors - Participant Feedback Using Rating Scale
time frame: Each study session was completed on a single day, for up to 60 minutes. Participant feedback using a rating scale was provided at approximately 50 minutes into the study session.
description: Participant will be asked to provide ratings on the following:
How would you rate the ease or difficulty using the device?
How clear or unclear was the Quick Start Guide?
How clear or unclear was the Packaging?
How clear or unclear was the User Manual?
How easy or difficult was it to understand and interpret the test results?
The participant will use the following rating scale (higher score = better outcome):
5 - Very Easy 4 - Easy 3 - Neither Easy nor Difficult 2 - Difficult
1 - Very difficult
For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes.
Participant will provide the ratings prior to the conclusion of the study session. Participant assessment with questionnaire rating scales will take approximately 1-2 minutes each.
arm group label: Pivot Breath Sensor (user group)
arm group type: Other
description: Self-reported daily smokers of 2 or more cigarettes per day
intervention type: Device
intervention name: Pivot Breath Sensor
description: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
arm group label: Pivot Breath Sensor (user group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Marler, MD
role: Principal Investigator
affiliation: Pivot Health Technologies Inc.
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Pivot Health Technologies Inc.
investigator full name: Jennifer Marler, MD
investigator title: Senior Director, Clinical and Medical Affairs
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 