<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/NCT02206399</url>
  </required_header>
  <id_info>
    <org_study_id>BLS-1</org_study_id>
    <nct_id>NCT02206399</nct_id>
  </id_info>
  <brief_title>Non-Invasive Hemoglobin Study</brief_title>
  <official_title>Non-Invasive Hemoglobin Multi-Center Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Convergence Biometrics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DRMiller Engineering</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Convergence Biometrics</source>
  <brief_summary>
    <textblock>
      The investigators clinical trials will be for a medical device that is non-invasive in&#xD;
      nature. The investigators will be studying whether their non-invasive medical device gets&#xD;
      data that is as good as, or better than, an FDA previously approved, blood analysis device.&#xD;
      There is no study hypothesis for this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Hemoglobin in Blood At Time of Test</measure>
    <time_frame>Up to 30 seconds</time_frame>
  </primary_outcome>
  <enrollment type="Actual">237</enrollment>
  <condition>Anemia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Whole Blood Donation Center Donors sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria for this study are:&#xD;
&#xD;
          1. Subject is capable of giving informed consent.&#xD;
&#xD;
          2. Subject has an anatomically intact digit capable of having a capillary sample taken&#xD;
             and of being placed in the POCT device.&#xD;
&#xD;
        Exclusion criteria for this study are:&#xD;
&#xD;
          1. Age less than 18 years at time of research&#xD;
&#xD;
          2. Subject lacks the digits to place in the POCT device&#xD;
&#xD;
          3. Subject displays symptoms or has a history of Raynaud's disease&#xD;
&#xD;
          4. Subject has a neurological disorder resulting in an inability to hold the index finger&#xD;
             steady for 20 sec.&#xD;
&#xD;
          5. Subject has a history of long term continuous decreased perfusion to either hand (&gt;30&#xD;
             days).&#xD;
&#xD;
          6. Subject has had surgery within the last 2 weeks on finger or hand that he wishes to&#xD;
             use in the study&#xD;
&#xD;
          7. Subject's same day participation in this study&#xD;
&#xD;
          8. Capillary sample volume is not adequate to complete testing on the comparative device.&#xD;
&#xD;
          9. Cold agglutinin disease&#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>
  <overall_official>
    <last_name>Anne Igbokwe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BloodSource</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chris Gresens, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BloodSource</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BloodSource</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95655-4128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>June 24, 2016</last_update_submitted>
  <last_update_submitted_qc>June 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02206399
org study id: BLS-1
nct id: NCT02206399
lead sponsor: 
collaborator: 
The investigators clinical trials will be for a medical device that is non-invasive in
      nature. The investigators will be studying whether their non-invasive medical device gets
      data that is as good as, or better than, an FDA previously approved, blood analysis device.
      There is no study hypothesis for this study.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Percentage of Hemoglobin in Blood At Time of Test
time frame: Up to 30 seconds
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anne Igbokwe, MD
role: Principal Investigator
affiliation: BloodSource
last name: Chris Gresens, MD
role: Principal Investigator
affiliation: BloodSource
facility: 
country: United States
responsible party type: Sponsor