xml: <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/NCT05980013</url>
    </required_header>
    <id_info>
      <org_study_id>ZMS-1500-Pa2023</org_study_id>
      <nct_id>NCT05980013</nct_id>
    </id_info>
    <brief_title>Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500</brief_title>
    <official_title>Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the Zynex Cardiac Monitor, Model 1500 (CM-1500)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zynex Monitoring Solutions</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zynex Monitoring Solutions</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 study is a prospective, non-randomized, non-blinded, non-significant risk study enrolling&#xD;
        up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure.&#xD;
        Subjects will wear the study device (CM-1500) while positioned in either a supine or reclined&#xD;
        position during the blood draw and study-required physiological parameters will be captured&#xD;
        pre-, during, and post-donation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 28, 2023</start_date>
    <completion_date type="Anticipated">January 22, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 22, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Impact of subject positioning on percent change of physiological parameters during minor blood loss</measure>
      <time_frame>At completion of blood draw</time_frame>
      <description>Percent change in heart rate, forearm skin temperature, bioelectrical impedance, ECG amplitude and PPG amplitude before and after blood draw in either a reclined or supine position.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Fluid Loss</condition>
    <condition>Blood Loss</condition>
    <arm_group>
      <arm_group_label>Supine Donation Position</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Reclined Donation Position</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Whole blood donation supine</intervention_name>
      <description>Subjects will undergo a 1-unit whole blood donation in a supine position</description>
      <arm_group_label>Supine Donation Position</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Whole blood donation reclined</intervention_name>
      <description>Subjects will undergo a 1-unit whole blood donation in a reclined position</description>
      <arm_group_label>Reclined Donation Position</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ability to provide written informed consent&#xD;
  &#xD;
            -  Ability and willingness to comply with the study procedures and duration requirements&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  Consented and eligible to undergo a single unit whole blood donation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Females who are pregnant or breastfeeding&#xD;
  &#xD;
            -  Undergone an amputation of any upper extremity&#xD;
  &#xD;
            -  Diagnosed with dextrocardia&#xD;
  &#xD;
            -  Subjects who have a pacemaker&#xD;
  &#xD;
            -  Subjects with body hair density which prevents adequate application of device&#xD;
               electrodes&#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_contact>
      <last_name>Kristin Andrud, PhD</last_name>
      <phone>(800) 495-6670</phone>
      <phone_ext>3457</phone_ext>
      <email>kandrud@zynex.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>SunCoast Blood Centers</name>
        <address>
          <city>Bradenton</city>
          <state>Florida</state>
          <zip>34211</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shelley Harkey</last_name>
        <phone>941-954-1600</phone>
        <phone_ext>10141</phone_ext>
        <email>sharkey@suncoastblood.org</email>
      </contact>
      <investigator>
        <last_name>Debra Smith, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980013
  org study id: ZMS-1500-Pa2023
  nct id: NCT05980013
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The study is a prospective, non-randomized, non-blinded, non-significant risk study enrolling
        up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure.
        Subjects will wear the study device (CM-1500) while positioned in either a supine or reclined
        position during the blood draw and study-required physiological parameters will be captured
        pre-, during, and post-donation.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Impact of subject positioning on percent change of physiological parameters during minor blood loss
  time frame: At completion of blood draw
  description: Percent change in heart rate, forearm skin temperature, bioelectrical impedance, ECG amplitude and PPG amplitude before and after blood draw in either a reclined or supine position.
  arm group label: Supine Donation Position
  arm group type: Experimental
  arm group label: Reclined Donation Position
  arm group type: Experimental
  intervention type: Device
  intervention name: Whole blood donation supine
  description: Subjects will undergo a 1-unit whole blood donation in a supine position
  arm group label: Supine Donation Position
  intervention type: Device
  intervention name: Whole blood donation reclined
  description: Subjects will undergo a 1-unit whole blood donation in a reclined position
  arm group label: Reclined Donation Position
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kristin Andrud, PhD
  phone: (800) 495-6670
  phone ext: 3457
  email: kandrud@zynex.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Hemorrhage
  sharing ipd: No