<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/NCT03239574</url>
  </required_header>
  <id_info>
    <org_study_id>TP-18810A</org_study_id>
    <nct_id>NCT03239574</nct_id>
  </id_info>
  <brief_title>MightySat - Clinical Performance Comparison Study</brief_title>
  <official_title>MightySat - Clinical Performance Comparison Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masimo Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masimo Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the performance of respiratory rate from pleth (RRp) measured with&#xD;
      MightySat device on healthy subjects.Subjects will be asked to breathe at specific rates&#xD;
      ranging from 5 to 30 breaths per minute.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Actual">July 20, 2017</completion_date>
  <primary_completion_date type="Actual">July 20, 2017</primary_completion_date>
  <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>Accuracy of RRp Determination</measure>
    <time_frame>approximately 30-40 minutes</time_frame>
    <description>Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the MightySat to the respiratory rate (RR) reference and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the MightySat RRp measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>MightySat Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MightySat</intervention_name>
    <description>MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study</description>
    <arm_group_label>MightySat Test group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 45 years old&#xD;
&#xD;
          -  Physical status of ASA I or II&#xD;
&#xD;
          -  Must be able to read and communicate in English&#xD;
&#xD;
          -  Has signed all necessary related documents, e.g. written informed consent,&#xD;
             confidentiality agreement&#xD;
&#xD;
          -  Passed health assessment screening&#xD;
&#xD;
          -  Negative pregnancy test for female subjects of child bearing potential&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years old, older than 45 years old&#xD;
&#xD;
          -  ASA physical status of III, IV, and V&#xD;
&#xD;
          -  Subject has any medical condition which in the judgement of the investigator, renders&#xD;
             them inappropriate for participation in the study&#xD;
&#xD;
          -  Inability to tolerate sitting still or minimal movement for at least 30 minutes&#xD;
&#xD;
          -  Positive pregnancy test for female subjects&#xD;
&#xD;
          -  Refusal to take pregnancy test for women of child bearing potential&#xD;
&#xD;
          -  Nursing female subjects&#xD;
&#xD;
          -  Refusal of male subjects to agree to shave hair off areas where sensors will be&#xD;
             applied (neck)&#xD;
&#xD;
          -  Excluded at Principal Investigator's discretion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Masimo Clinical Lab</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <results_first_submitted>June 17, 2020</results_first_submitted>
  <results_first_submitted_qc>December 30, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 31, 2020</results_first_posted>
  <disposition_first_submitted>June 22, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>December 30, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 31, 2020</disposition_first_posted>
  <last_update_submitted>December 30, 2020</last_update_submitted>
  <last_update_submitted_qc>December 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>June 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03239574/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MightySat Test Group</title>
          <description>The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.&#xD;
MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </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>MightySat Test Group</title>
          <description>The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.&#xD;
MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </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>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian or Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Middle Eastern</title>
              <category_list>
                <category>
                  <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="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Accuracy of RRp Determination</title>
        <description>Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the MightySat to the respiratory rate (RR) reference and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the MightySat RRp measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.</description>
        <time_frame>approximately 30-40 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MightySat Test Group</title>
            <description>The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.&#xD;
MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Accuracy of RRp Determination</title>
          <description>Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the MightySat to the respiratory rate (RR) reference and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the MightySat RRp measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.</description>
          <units>breaths per minute</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 week</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MightySat Test Group</title>
          <description>The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.&#xD;
MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study</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="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
              </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="34"/>
              </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>Ahmed Alghazi</name_or_title>
      <organization>Masimo</organization>
      <phone>949-297-7000</phone>
      <email>studies@masimo.com</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/NCT03239574
org study id: TP-18810A
nct id: NCT03239574
lead sponsor: 
has dmc: No
is unapproved device: Yes
This study compares the performance of respiratory rate from pleth (RRp) measured with
      MightySat device on healthy subjects.Subjects will be asked to breathe at specific rates
      ranging from 5 to 30 breaths per minute.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Accuracy of RRp Determination
time frame: approximately 30-40 minutes
description: Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the MightySat to the respiratory rate (RR) reference and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the MightySat RRp measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
arm group label: MightySat Test group
arm group type: Experimental
description: The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.
intervention type: Device
intervention name: MightySat
description: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study
arm group label: MightySat Test group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 