<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/NCT03828487</url>
  </required_header>
  <id_info>
    <org_study_id>RAMA0004</org_study_id>
    <nct_id>NCT03828487</nct_id>
  </id_info>
  <brief_title>Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates</brief_title>
  <official_title>Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masimo Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masimo Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to compare the performance of the O3 cerebral oximeter and sensor to&#xD;
      a 510(k) cleared NIRS (Near-Infrared Spectroscopy) device on neonatal subjects based on data&#xD;
      collected from the cutaneously placed forehead sensors. Due to the design of the systems, the&#xD;
      devices will be used serially instead of concurrently. Because of this timing, changes in&#xD;
      patient state may not be reflected in measurements collected by both devices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor terminated study due to project timeline.&#xD;
  </why_stopped>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Actual">June 14, 2019</completion_date>
  <primary_completion_date type="Actual">June 14, 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>Number of Participants With rSO2 Collected</measure>
    <time_frame>Data collection period; alternating sensors every 5 minutes for up to 20 minutes.</time_frame>
    <description>In order to obtain the RMS value, rSO2 values collected from the control device (510(k) cleared regional oximetry sensor) is subtracted from the rSO2 values collected from the investigational device (Masimo O3 neonatal sensors) 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 RMS Error value.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Regional Saturation of Oxygen (rSO2)</condition>
  <arm_group>
    <arm_group_label>Neonatal Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Masimo O3 Neonatal Sensors</intervention_name>
    <description>Regional Oximetry sensor for Neonates</description>
    <arm_group_label>Neonatal Test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>510(k) cleared sensor</intervention_name>
    <description>Cleared Regional Oximetry sensor for Neonates</description>
    <arm_group_label>Neonatal Test group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Less than 10 kg&#xD;
&#xD;
          -  Subjects less than or equal to 28 days old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Underdeveloped skin at sites of sensor placement&#xD;
&#xD;
          -  Jaundice or bilirubin levels out of normal range&#xD;
&#xD;
          -  Subject has skin abnormalities affecting the sensor placement area such as psoriasis,&#xD;
             eczema, angioma, scar tissue, burn, fungal infection, or substantial skin breakdown&#xD;
             that would prevent monitoring of oxygenation levels during the study&#xD;
&#xD;
          -  Subject deemed not eligible based on Principal Investigator's judgment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <results_first_submitted>May 6, 2020</results_first_submitted>
  <results_first_submitted_qc>May 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 7, 2021</results_first_posted>
  <last_update_submitted>May 11, 2021</last_update_submitted>
  <last_update_submitted_qc>May 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03828487/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Neonatal Test Group</title>
          <description>Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.&#xD;
Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates&#xD;
510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Neonatal Test Group</title>
          <description>Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.&#xD;
Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates&#xD;
510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
          </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="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With rSO2 Collected</title>
        <description>In order to obtain the RMS value, rSO2 values collected from the control device (510(k) cleared regional oximetry sensor) is subtracted from the rSO2 values collected from the investigational device (Masimo O3 neonatal sensors) 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 RMS Error value.</description>
        <time_frame>Data collection period; alternating sensors every 5 minutes for up to 20 minutes.</time_frame>
        <population>Study was prematurely terminated. Study did not reach the target number of subjects needed to achieve minimum sample size determination and was insufficient to produce statistically reliable results.</population>
        <group_list>
          <group group_id="O1">
            <title>Neonatal Test Group</title>
            <description>Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.&#xD;
Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates&#xD;
510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With rSO2 Collected</title>
          <description>In order to obtain the RMS value, rSO2 values collected from the control device (510(k) cleared regional oximetry sensor) is subtracted from the rSO2 values collected from the investigational device (Masimo O3 neonatal sensors) 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 RMS Error value.</description>
          <population>Study was prematurely terminated. Study did not reach the target number of subjects needed to achieve minimum sample size determination and was insufficient to produce statistically reliable results.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Neonatal Test Group</title>
          <description>Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.&#xD;
Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates&#xD;
510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates</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="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
              </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="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study did not reach the target number of subjects needed to achieve minimum sample size determination and was insufficient to produce statistically reliable results.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Vikram Ramakanth</name_or_title>
      <organization>Masimo Corporation</organization>
      <phone>949-297-7416</phone>
      <email>clinicalresearchdept@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/NCT03828487
org study id: RAMA0004
nct id: NCT03828487
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
The aim of the study is to compare the performance of the O3 cerebral oximeter and sensor to
      a 510(k) cleared NIRS (Near-Infrared Spectroscopy) device on neonatal subjects based on data
      collected from the cutaneously placed forehead sensors. Due to the design of the systems, the
      devices will be used serially instead of concurrently. Because of this timing, changes in
      patient state may not be reflected in measurements collected by both devices.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of Participants With rSO2 Collected
time frame: Data collection period; alternating sensors every 5 minutes for up to 20 minutes.
description: In order to obtain the RMS value, rSO2 values collected from the control device (510(k) cleared regional oximetry sensor) is subtracted from the rSO2 values collected from the investigational device (Masimo O3 neonatal sensors) 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 RMS Error value.
arm group label: Neonatal Test group
arm group type: Experimental
description: Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.
intervention type: Device
intervention name: Masimo O3 Neonatal Sensors
description: Regional Oximetry sensor for Neonates
arm group label: Neonatal Test group
intervention type: Device
intervention name: 510(k) cleared sensor
description: Cleared Regional Oximetry sensor for Neonates
arm group label: Neonatal Test group
criteria: 
gender: All
minimum age: N/A
maximum age: 28 Days
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study did not reach the target number of subjects needed to achieve minimum sample size determination and was insufficient to produce statistically reliable results.
point of contact: 