<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/NCT04490863</url>
  </required_header>
  <id_info>
    <org_study_id>SDBB0005</org_study_id>
    <nct_id>NCT04490863</nct_id>
  </id_info>
  <brief_title>Noninvasive Hemoglobin Repeatability and Reproducibility in a Blood Donation Setting</brief_title>
  <official_title>Noninvasive Hemoglobin Spot Check Repeatability and Reproducibility in a Blood Donation Setting</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_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this clinical investigation is to report on the repeatability and&#xD;
      reproducibility of SpHb measurements from Rad-67 devices and DCI Mini sensors used to screen&#xD;
      prospective blood donors at a donation center.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Actual">August 20, 2020</completion_date>
  <primary_completion_date type="Actual">August 20, 2020</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>Coefficient of Variation of Rad-67</measure>
    <time_frame>Approximately 90 minutes per subject</time_frame>
    <description>Coefficient of variation will be computed using Repeatability and Reproducibility variance.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Healthy</condition>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Test subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects are enrolled and receive Rad-67 Pulse oximeter &amp; DCI Mini sensor for measurement of hemoglobin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rad-67 Pulse oximeter &amp; DCI Mini sensor</intervention_name>
    <description>Noninvasive pulse oximeter that measures hemoglobin</description>
    <arm_group_label>Test subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Weight at least 110 pounds&#xD;
&#xD;
          -  Subjects with the intention of being screened for eligibility to donate blood&#xD;
&#xD;
          -  The subject has given written informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with skin abnormalities at the planned application sites that may interfere&#xD;
             with sensor application, per directions-for-use (DFU) or trans-illumination of the&#xD;
             site, such as burns, scar tissue, infections, abnormalities, etc.&#xD;
&#xD;
          -  Subjects unwilling to remove nail polish or acrylic nails&#xD;
&#xD;
          -  Subjects with blood cancers such as leukemia&#xD;
&#xD;
          -  Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia or with&#xD;
             known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc.&#xD;
&#xD;
          -  Subjects with self-disclosed/known pregnancy at the time of enrollment&#xD;
&#xD;
          -  Subjects deemed not suitable for the study at the discretion of the investigator&#xD;
&#xD;
          -  Subjects unlikely to be able to refrain from excessive motion during data collection.&#xD;
             Excessive motion includes postural changes, making hand gestures, involuntary muscular&#xD;
             movements, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Blood Bank - Site 1</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <results_first_submitted>July 6, 2021</results_first_submitted>
  <results_first_submitted_qc>August 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 31, 2021</results_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 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>June 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT04490863/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Test Subjects</title>
          <description>All subjects are enrolled and receive Rad-67 Pulse oximeter &amp; DCI Mini sensor for measurement of hemoglobin.&#xD;
Rad-67 Pulse oximeter &amp; DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </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>Test Subjects</title>
          <description>All subjects are enrolled and receive Rad-67 Pulse oximeter &amp; DCI Mini sensor for measurement of hemoglobin.&#xD;
Rad-67 Pulse oximeter &amp; DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
          </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </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>Race</title>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More Than One Race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mexican</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Middle Eastern</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="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Coefficient of Variation of Rad-67</title>
        <description>Coefficient of variation will be computed using Repeatability and Reproducibility variance.</description>
        <time_frame>Approximately 90 minutes per subject</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Subjects</title>
            <description>All subjects are enrolled and receive Rad-67 Pulse oximeter &amp; DCI Mini sensor for measurement of hemoglobin.&#xD;
Rad-67 Pulse oximeter &amp; DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin</description>
          </group>
        </group_list>
        <measure>
          <title>Coefficient of Variation of Rad-67</title>
          <description>Coefficient of variation will be computed using Repeatability and Reproducibility variance.</description>
          <units>Coefficient of Variation percentage</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 90 minutes per subject</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Subjects</title>
          <description>All subjects are enrolled and receive Rad-67 Pulse oximeter &amp; DCI Mini sensor for measurement of hemoglobin.&#xD;
Rad-67 Pulse oximeter &amp; DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin</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="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
              </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="26"/>
              </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>
    <point_of_contact>
      <name_or_title>Vikram Ramakanth</name_or_title>
      <organization>Masimo Corporation</organization>
      <phone>949-297-7000</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/NCT04490863
org study id: SDBB0005
nct id: NCT04490863
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The primary objective of this clinical investigation is to report on the repeatability and
      reproducibility of SpHb measurements from Rad-67 devices and DCI Mini sensors used to screen
      prospective blood donors at a donation center.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Coefficient of Variation of Rad-67
time frame: Approximately 90 minutes per subject
description: Coefficient of variation will be computed using Repeatability and Reproducibility variance.
arm group label: Test subjects
arm group type: Experimental
description: All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin.
intervention type: Device
intervention name: Rad-67 Pulse oximeter & DCI Mini sensor
description: Noninvasive pulse oximeter that measures hemoglobin
arm group label: Test subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 