<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/NCT03273166</url>
  </required_header>
  <id_info>
    <org_study_id>TP-18788</org_study_id>
    <nct_id>NCT03273166</nct_id>
  </id_info>
  <brief_title>Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution</brief_title>
  <official_title>Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study involves comparison of the performance of two SpHb sensors in subjects that&#xD;
      undergo a hemodilution procedure. The sensors' performance will be assessed by comparison of&#xD;
      the measured hemoglobin values against reference values obtained by a laboratory hematology&#xD;
      analyzer. Blood samples will be collected from healthy volunteers who undergo a hemodilution&#xD;
      procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced&#xD;
      by administering intravenous fluids to the volunteer in a controlled manner.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 29, 2017</start_date>
  <completion_date type="Actual">September 18, 2017</completion_date>
  <primary_completion_date type="Actual">September 18, 2017</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>Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation</measure>
    <time_frame>1-5 hours</time_frame>
    <description>Performance of the sensors will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the pulse oximeter sensors to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square(ARMS) value.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>INVSENSOR00001 sensor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a nonrandomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>INVSENSOR00001</intervention_name>
    <description>This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.</description>
    <arm_group_label>INVSENSOR00001 sensor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control SpHb sensor</intervention_name>
    <description>This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.</description>
    <arm_group_label>INVSENSOR00001 sensor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hemodilution</intervention_name>
    <description>This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers while undergoing a hemodilution procedure.</description>
    <arm_group_label>INVSENSOR00001 sensor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Competent adults between the ages of 18 and 50 years of age&#xD;
&#xD;
          -  Must weigh a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet&#xD;
             tall&#xD;
&#xD;
          -  BMI ≤ 35 unless the physician determines that a higher BMI is not due to morbid&#xD;
             obesity, to safeguard subject safety during hemodilution&#xD;
&#xD;
          -  Must have a hemoglobin value ≥ 11 g/dL at time of screening, to safeguard subject&#xD;
             safety during hemodilution&#xD;
&#xD;
          -  Baseline heart rate between 45 bpm and 85 bpm&#xD;
&#xD;
          -  CO value less than 2.0% FCOHb&#xD;
&#xD;
          -  Physical status of ASA I or II (American Society of Anesthesiology Class I; Healthy&#xD;
             subjects without any systemic disease at all. American Society of Anesthesiology Class&#xD;
             II; subjects with mild systemic disease) The ASA definition strictly applies to the&#xD;
             systemic disease portion of the classification&#xD;
&#xD;
          -  Systolic BP less than or equal to 140 mmHg and Diastolic BP less than or equal to 90&#xD;
             mmHg&#xD;
&#xD;
          -  Able to read and communicate in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or positive hCG test&#xD;
&#xD;
          -  Smokers (including e-cigarette users)&#xD;
&#xD;
          -  Subject has known drug or alcohol abuse. Subjects who uses recreational drugs&#xD;
&#xD;
          -  Subject has experienced a concussion or head injury with loss of consciousness within&#xD;
             the last year&#xD;
&#xD;
          -  Any chronic bleeding disorders (i.e. hemophilia)&#xD;
&#xD;
          -  Any history of a stroke, myocardial infarction, or seizures&#xD;
&#xD;
          -  Any cancer or history of cancer (not including skin cancer)&#xD;
&#xD;
          -  Chronic neurological diseases (i.e. multiple sclerosis, Huntington's Disease)&#xD;
&#xD;
          -  Any cardiac dysrhythmias (i.e. atrial fibrillation)(without physicians clearance)&#xD;
&#xD;
          -  Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia,&#xD;
             bipolar disorder) that interferes with the subject's level of consciousness&#xD;
&#xD;
          -  Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome&#xD;
&#xD;
          -  Subjects who have/are currently taking anticoagulant medication&#xD;
&#xD;
          -  Subjects who have taken opioid pain medication within 24 hours of start of study&#xD;
&#xD;
          -  Subjects who do not understand the study and the risks&#xD;
&#xD;
          -  Subjects having either signs or history of peripheral ischemia&#xD;
&#xD;
          -  Subjects who have had invasive surgery within the past year- including but not limited&#xD;
             to major dental surgery, gallbladder, heart, appendix, major fracture repairs&#xD;
             (involving plates/ screws), jaw surgery, urinary tract surgery, plastic surgery, major&#xD;
             ENT surgery, joint replacement or gynecological surgeries, heart surgery or thoracic&#xD;
             surgery&#xD;
&#xD;
          -  Subjects that have symptoms of congestion, head colds, flu, or other illnesses&#xD;
&#xD;
          -  Subjects with claustrophobia, or generalized anxiety disorder&#xD;
&#xD;
          -  Subjects who have been in severe car accident(s) or a similar type of accident(s)&#xD;
             requiring hospitalization within the last 12 months&#xD;
&#xD;
          -  Subjects with chronic unresolved asthma, lung disease and respiratory disease&#xD;
&#xD;
          -  Subjects with allergies to lidocaine, latex, adhesives, or plastic&#xD;
&#xD;
          -  Subjects with heart conditions, insulin-dependent diabetes or uncontrolled&#xD;
             hypertension&#xD;
&#xD;
          -  Subjects who have given vaginal delivery, had a pregnancy terminated, a miscarriage&#xD;
             with hospitalization or had a c-section within the last 6 months&#xD;
&#xD;
          -  Subjects who intend on participating in any heavy lifting, repetitive movement of&#xD;
             their wrist (including riding a motorcycle) or exercise (working out, riding a bike,&#xD;
             riding a skate board etc.), or any activity that will put additional stress on the&#xD;
             wrist within 24 hours following a study involving an arterial blood draw and/or&#xD;
             arterial line placement&#xD;
&#xD;
          -  Subject has any medical condition which in the judgment of the investigator and/or&#xD;
             medical staff, renders them ineligible for participation in this study (Discretion of&#xD;
             investigator)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 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>October 2020</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <results_first_submitted>September 11, 2020</results_first_submitted>
  <results_first_submitted_qc>October 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 26, 2020</results_first_posted>
  <disposition_first_submitted>September 18, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>October 22, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 26, 2020</disposition_first_posted>
  <last_update_submitted>October 22, 2020</last_update_submitted>
  <last_update_submitted_qc>October 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2020</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>May 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03273166/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Fingers were not randomized to the two interventions. All participants received both interventions in the exact same manner.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>INVSENSOR00001</title>
          <description>All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawn prior to Completion</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>INVSENSOR00001</title>
          <description>All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="51"/>
          </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="50"/>
                  </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="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </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/Ethnicity, Customized</title>
              <category_list>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian or Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native American</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="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation</title>
        <description>Performance of the sensors will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the pulse oximeter sensors to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square(ARMS) value.</description>
        <time_frame>1-5 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>INVSENSOR00001</title>
            <description>All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.</description>
          </group>
          <group group_id="O2">
            <title>Control SpHb Sensor</title>
            <description>All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation</title>
          <description>Performance of the sensors will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the pulse oximeter sensors to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square(ARMS) value.</description>
          <units>g/dL</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 to 5 hours</time_frame>
      <desc>Adverse Events were not collected with respect to the interventions, only on participants as a whole.</desc>
      <group_list>
        <group group_id="E1">
          <title>INVSENSOR00001</title>
          <description>All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.</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="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Irregular EKG readings</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
              </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>Chelsea Frank</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/NCT03273166
org study id: TP-18788
nct id: NCT03273166
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study involves comparison of the performance of two SpHb sensors in subjects that
      undergo a hemodilution procedure. The sensors' performance will be assessed by comparison of
      the measured hemoglobin values against reference values obtained by a laboratory hematology
      analyzer. Blood samples will be collected from healthy volunteers who undergo a hemodilution
      procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced
      by administering intravenous fluids to the volunteer in a controlled manner.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation
time frame: 1-5 hours
description: Performance of the sensors will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the pulse oximeter sensors to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square(ARMS) value.
arm group label: INVSENSOR00001 sensor
arm group type: Experimental
description: This is a nonrandomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.
intervention type: Device
intervention name: INVSENSOR00001
description: This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.
arm group label: INVSENSOR00001 sensor
intervention type: Device
intervention name: Control SpHb sensor
description: This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.
arm group label: INVSENSOR00001 sensor
intervention type: Procedure
intervention name: Hemodilution
description: This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers while undergoing a hemodilution procedure.
arm group label: INVSENSOR00001 sensor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
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: 