<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/NCT04450381</url>
  </required_header>
  <id_info>
    <org_study_id>SDBB0004</org_study_id>
    <nct_id>NCT04450381</nct_id>
  </id_info>
  <brief_title>Noninvasive Hemoglobin Testing, Prospective Blood Donors</brief_title>
  <official_title>Noninvasive Hemoglobin Testing in Prospective Blood Donors</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 objective of this clinical investigation is to evaluate the pulse oximeter devices for&#xD;
      screening prospective blood donors. The purpose study is to report on the accuracy of&#xD;
      noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a&#xD;
      laboratory hematology analyzer in a blood donation setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Actual">July 7, 2020</completion_date>
  <primary_completion_date type="Actual">July 7, 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>Rad-67 Sensitivity</measure>
    <time_frame>Up to one hour per subject</time_frame>
    <description>Sensitivity of the the Rad-67 will be determined for its use in a blood donation center</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rad-67 Specificity</measure>
    <time_frame>Up to one hour per subject</time_frame>
    <description>Specificity of the the Rad-67 will be determined for its use in a blood donation center</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">131</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 and/or unable 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&#xD;
&#xD;
          -  Subjects with known history of infectious diseases such as HIV/AIDS, syphilis,&#xD;
             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;
          -  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>July 2021</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <results_first_submitted>July 6, 2021</results_first_submitted>
  <results_first_submitted_qc>July 6, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 27, 2021</results_first_posted>
  <last_update_submitted>July 6, 2021</last_update_submitted>
  <last_update_submitted_qc>July 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 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 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT04450381/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 the Pulse oximeter &amp; 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="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Wrong device setting</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_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="125"/>
          </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="106"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </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="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </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>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More Than One Race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other: American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other: Assyrian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other: Mexican</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other: Native American</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="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rad-67 Sensitivity</title>
        <description>Sensitivity of the the Rad-67 will be determined for its use in a blood donation center</description>
        <time_frame>Up to one hour per subject</time_frame>
        <population>2 subjects were excluded from analysis due to wrong device setting</population>
        <group_list>
          <group group_id="O1">
            <title>Test Subjects</title>
            <description>All subjects are enrolled and receive the Pulse oximeter &amp; 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>Rad-67 Sensitivity</title>
          <description>Sensitivity of the the Rad-67 will be determined for its use in a blood donation center</description>
          <population>2 subjects were excluded from analysis due to wrong device setting</population>
          <units>percentage of sensitivity</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rad-67 Specificity</title>
        <description>Specificity of the the Rad-67 will be determined for its use in a blood donation center</description>
        <time_frame>Up to one hour per subject</time_frame>
        <population>2 subjects were excluded from analysis due to wrong device setting</population>
        <group_list>
          <group group_id="O1">
            <title>Test Subjects</title>
            <description>All subjects are enrolled and receive the Pulse oximeter &amp; 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>Rad-67 Specificity</title>
          <description>Specificity of the the Rad-67 will be determined for its use in a blood donation center</description>
          <population>2 subjects were excluded from analysis due to wrong device setting</population>
          <units>percentage of specificity</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to one hour per subject</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Subjects</title>
          <description>All subjects are enrolled and receive the Pulse oximeter &amp; 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="131"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="131"/>
              </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="131"/>
              </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>clincalresearchdept@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/NCT04450381
org study id: SDBB0004
nct id: NCT04450381
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The objective of this clinical investigation is to evaluate the pulse oximeter devices for
      screening prospective blood donors. The purpose study is to report on the accuracy of
      noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a
      laboratory hematology analyzer in a blood donation setting.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Rad-67 Sensitivity
time frame: Up to one hour per subject
description: Sensitivity of the the Rad-67 will be determined for its use in a blood donation center
measure: Rad-67 Specificity
time frame: Up to one hour per subject
description: Specificity of the the Rad-67 will be determined for its use in a blood donation center
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: 