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/NCT05978453</url>
    </required_header>
    <id_info>
      <org_study_id>Andon Health 11</org_study_id>
      <nct_id>NCT05978453</nct_id>
    </id_info>
    <brief_title>Blood Pressure Monitor Clinical Test (Cuff Range: 13.5cm-22cm)</brief_title>
    <official_title>Blood Pressure Monitor#Model#BP7# Clincial Test</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Andon Health Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Andon Health Co., Ltd</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to verify the accurancy of the blood pressure monitor device.&#xD;
  &#xD;
        Cuff size of arm circumference: 13.5cm- 22cm.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 7, 2021</start_date>
    <completion_date type="Actual">June 30, 2021</completion_date>
    <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>blood pressure monitor accurancy</measure>
      <time_frame>30 minutes</time_frame>
      <description>All the test results of the electronic blood pressure monitor is within the accuracy creteria, with the merury sphygmomanometer as control</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">90</enrollment>
    <condition>Blood Pressure</condition>
    <arm_group>
      <arm_group_label>Subject use both BP7 Wrist Automatic Electronic BPM and mercury sphygmomanometers</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Normal blood pressure and hypertensive patients over 12 years old&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Normal blood pressure and hypertensive patients over 12 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with serious arrhythmias or a high frequency of arrhythmias&#xD;
  &#xD;
            -  pregnant woman&#xD;
  &#xD;
            -  Other investigators believe that it is not suitable to participate in this clinical&#xD;
               trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300190</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>March 2022</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT05978453
  org study id: Andon Health 11
  nct id: NCT05978453
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this study is to verify the accurancy of the blood pressure monitor device.
  
        Cuff size of arm circumference: 13.5cm- 22cm.
  observational model: Other
  time perspective: Prospective
  measure: blood pressure monitor accurancy
  time frame: 30 minutes
  description: All the test results of the electronic blood pressure monitor is within the accuracy creteria, with the merury sphygmomanometer as control
  arm group label: Subject use both BP7 Wrist Automatic Electronic BPM and mercury sphygmomanometers
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No