<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/NCT03013842</url>
  </required_header>
  <id_info>
    <org_study_id>828902</org_study_id>
    <nct_id>NCT03013842</nct_id>
  </id_info>
  <brief_title>Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects</brief_title>
  <official_title>Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CITRIS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human&#xD;
      subjects, in order to obtain fetal heart rate.&#xD;
&#xD;
      We want to determine if this device can accurately measure a baby's oxygen level when placed&#xD;
      on your abdomen.&#xD;
&#xD;
      Current technology to measure a baby's oxygen levels requires a probe to be inserted into the&#xD;
      vagina.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study subject will have a brief trans-abdominal ultrasound examination.&#xD;
&#xD;
      3 trans-abdominal fetal oximetry probes will be tested for 5 minutes per probe. No probes&#xD;
      will be placed into the vagina.&#xD;
&#xD;
      It is anticipated that 6 months will be required to recruit, consent and study 25&#xD;
      participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Principal Investigator no longer at Site&#xD;
  </why_stopped>
  <start_date type="Actual">December 12, 2016</start_date>
  <completion_date type="Actual">August 2, 2017</completion_date>
  <primary_completion_date type="Actual">August 2, 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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fetal Photoplethysmogram</measure>
    <time_frame>6 months</time_frame>
    <description>The primary outcome measure will be if a fetal photoplethysmogram is obtained in the time domain that correlates to the fetal heart rate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fetal Heart Rate</measure>
    <time_frame>6 months</time_frame>
    <description>The secondary endpoint will be if fetal heart rate can be obtained in the frequency domain that correlates to a fetal heart rate obtained by Doppler.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Pregnancy, Abdominal</condition>
  <arm_group>
    <arm_group_label>Administration of Fetal Oximetry Probe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of Raydiant Oximetry Sensor System on 36 weeks or greater pregnant women</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Raydiant Oximetry Sensor System</intervention_name>
    <description>Administration of Fetal Oximetry Probe on 36 weeks or greater pregnant women</description>
    <arm_group_label>Administration of Fetal Oximetry Probe</arm_group_label>
    <other_name>ROSS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Greater than 36 weeks pregnant&#xD;
&#xD;
          -  Singleton fetus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil Ray, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>916-734-5028</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 29, 2018</last_update_submitted>
  <last_update_submitted_qc>January 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>fetal monitoring</keyword>
  <keyword>fetal oximetry</keyword>
  <keyword>fetal heart rate</keyword>
  <keyword>pulse oximetry</keyword>
  <keyword>near infrared spectroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy, Abdominal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03013842
org study id: 828902
nct id: NCT03013842
lead sponsor: 
collaborator: 
has dmc: No
Three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human
      subjects, in order to obtain fetal heart rate.

      We want to determine if this device can accurately measure a baby's oxygen level when placed
      on your abdomen.

      Current technology to measure a baby's oxygen levels requires a probe to be inserted into the
      vagina.
The study subject will have a brief trans-abdominal ultrasound examination.

      3 trans-abdominal fetal oximetry probes will be tested for 5 minutes per probe. No probes
      will be placed into the vagina.

      It is anticipated that 6 months will be required to recruit, consent and study 25
      participants.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Fetal Photoplethysmogram
time frame: 6 months
description: The primary outcome measure will be if a fetal photoplethysmogram is obtained in the time domain that correlates to the fetal heart rate.
measure: Fetal Heart Rate
time frame: 6 months
description: The secondary endpoint will be if fetal heart rate can be obtained in the frequency domain that correlates to a fetal heart rate obtained by Doppler.
arm group label: Administration of Fetal Oximetry Probe
arm group type: Experimental
description: Administration of Raydiant Oximetry Sensor System on 36 weeks or greater pregnant women
intervention type: Device
intervention name: Raydiant Oximetry Sensor System
description: Administration of Fetal Oximetry Probe on 36 weeks or greater pregnant women
arm group label: Administration of Fetal Oximetry Probe
other name: ROSS
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Neil Ray, MD
role: Principal Investigator
affiliation: 916-734-5028
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pregnancy, Abdominal
sharing ipd: No