<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/NCT01662947</url>
  </required_header>
  <id_info>
    <org_study_id>Wrist BPM TMB-1117</org_study_id>
    <secondary_id>BTS-TRANS12001</secondary_id>
    <nct_id>NCT01662947</nct_id>
  </id_info>
  <brief_title>Clinical Study of Wrist Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10 Standard</brief_title>
  <acronym>WristBPM01</acronym>
  <official_title>Verify Wrist BPM TMB-1117 to Comply With ANSI/AAMI SP10</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leo Wang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BTS International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>BTS International</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical protocol of the clinical testing of this device:&#xD;
&#xD;
        1. Objective of the test: To verify the efficiency of device.&#xD;
&#xD;
        2. Test methods and procedures: Clinical test in two positions: Seated and Supine.&#xD;
&#xD;
        3. DUT: Transtek Wrist Blood Pressure Monitor, Model: TMB-1117. Cuff size: 13.5 - 21.5 cm.&#xD;
&#xD;
        4. Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and&#xD;
           range: 0-300 mmHg.&#xD;
&#xD;
        5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.&#xD;
&#xD;
        6. Statistical methodology used: Description of statistical methods.&#xD;
&#xD;
        7. Result: Meet the requirements of SP10.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hospital Information&#xD;
&#xD;
      Hospital Information The data was collected by Zhongshan City People's Hospital Clinical&#xD;
      Investigator Team at Zhongshan City People's Hospital, No.2 Sunwen Dong Road, Zhongshan,&#xD;
      Guangdong 528403, P. R. China.&#xD;
&#xD;
      Investigator: Dr. Cao Yuedong, Leader; Li Qidong, Nurse A; Chen Wenqian, Nurse B.&#xD;
&#xD;
      Contact Dr. Cao Yuedong Tel: +86 760 88823818&#xD;
&#xD;
      Used Equipments DUT (Device Under Test): Transtek Wrist Blood Pressure Monitor, TMB-1117&#xD;
      Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and range:&#xD;
      0-300 mmHg.&#xD;
&#xD;
      Test Protocol&#xD;
&#xD;
        1. Test Purpose:&#xD;
&#xD;
           The aim of clinical test is to determine, for the purpose of design qualification, the&#xD;
           overall performance of the system meeting the following requirement: For systolic and&#xD;
           diastolic pressures, treated separately, the mean difference of the paired measurement&#xD;
           of the test system and the comparison system shall be ± 5 mmHg or less, with standard&#xD;
           deviation of 8 mmHg or less.&#xD;
&#xD;
        2. Target Subject:&#xD;
&#xD;
      1) The subject database shall contain at least 85 subjects. 2) The distribution of blood&#xD;
      pressure of the subjects required to be: At least 10 percent below 100 mmHg systolic; at&#xD;
      least 10 percent above 160 mmHg systolic; at least 10 percent below 60 mmHg diastolic; at&#xD;
      least 10 percent above 100 mmHg diastolic; with the remainder distributed between these outer&#xD;
      limits.&#xD;
&#xD;
      3. Identification and precision of equipment used According to ANSI/AAMI SP10, the maximum&#xD;
      measurement error of the non-automatic sphygmomanometers used in the comparing test shall not&#xD;
      exceed 1.0mmHg at the temperature of the test. The manometer was used to verify its accuracy&#xD;
      before test.&#xD;
&#xD;
      The clinical study was conducted according to the protocol described in the ANSI/AAMI SP10&#xD;
      with 85 subjects.&#xD;
&#xD;
      4. Test procedures (auscultatory method, same-limb sequential measurement was chosen)&#xD;
&#xD;
        1. Record the age, gender, and circumference of the left wrist of the subject.&#xD;
&#xD;
        2. Let subject seated or supine calmly for five minutes before test.&#xD;
&#xD;
        3. Measure heart rate in one minute by palpation on radial artery, record it.&#xD;
&#xD;
        4. Two observers shall make simultaneous, blinded, blood pressure determination on the&#xD;
           subject's left arm. Each nurse will write down the reading on a small piece of paper,&#xD;
           make a tick if there is an auscultatory gap and then submit to the recorder.&#xD;
&#xD;
        5. The two readings separately from two observers will be recorded, and if two observers&#xD;
           agree that they find an auscultatory gap this time, it will also be recorded. The wrist&#xD;
           cuff will be take off, after 90 seconds rest, TMB-1117 cuff will be taken on and tested,&#xD;
           and the readings (systolic, diastolic, mean BP and Heart rate) be recorded.&#xD;
&#xD;
        6. For each subject, repeat 3) and 5) to get 3 measurements.&#xD;
&#xD;
        7. Repeat step 1) to 6) for every subject.&#xD;
&#xD;
      5. Note:&#xD;
&#xD;
        1. No motion and speaking are allowed during the measurement.&#xD;
&#xD;
        2. The reference device's cuff release at the rate about 3 mmHg/s so to ensure an accurate&#xD;
           reading of observer.&#xD;
&#xD;
        3. The arm, wrist and the haear of subject to keep on the same height when measurement.&#xD;
&#xD;
        4. Test environment: Temperature: 20±1 ℃; Relative humidity: 40~50%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Factorial Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Verify the accuracy of measure functions of device</measure>
    <time_frame>10 days</time_frame>
    <description>Verify the accuracy of device if meet the requirements of ANSI/AAMI SP10 when it measure Systolic &amp; Diastolic blood pressure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Efficacy of Wrist BPM Measurement</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>DUT Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DUT: Transtek Wrist Blood Pressure Monitor TMB-1117&#xD;
Measurement: Blood Pressure&#xD;
Groups/Cohorts: DUT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1mmHg and range: 0-300mmHg.&#xD;
Measurement: Blood Pressure&#xD;
Groups/Cohorts: Reference</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117</intervention_name>
    <description>Systolic, Diastolic pressure.</description>
    <arm_group_label>DUT Arm</arm_group_label>
    <other_name>DUT TMB-1117 measurement</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2</intervention_name>
    <description>Systolic, Diastolic pressure</description>
    <arm_group_label>Reference Arm</arm_group_label>
    <other_name>Reference mercury sphygmomanometer measurement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male,female,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  below 18 years old&#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>Leo Wang, Leader</last_name>
    <role>Study Chair</role>
    <affiliation>BTS International</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongshan City People's Hospital</name>
      <address>
        <city>Zhongshan</city>
        <state>Guangdong</state>
        <zip>528403</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.zsph.com</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Alpert BS. Validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitor to the ISO Standard and BHS protocol. Blood Press Monit. 2010 Oct;15(5):275-7. doi: 10.1097/MBP.0b013e32833c8b39.</citation>
    <PMID>20559140</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>August 8, 2012</last_update_submitted>
  <last_update_submitted_qc>August 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>BTS International</investigator_affiliation>
    <investigator_full_name>Leo Wang</investigator_full_name>
    <investigator_title>Team leader</investigator_title>
  </responsible_party>
  <keyword>blood pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT01662947
org study id: Wrist BPM TMB-1117
secondary id: BTS-TRANS12001
nct id: NCT01662947
lead sponsor: 
collaborator: 
has dmc: No
The clinical protocol of the clinical testing of this device:

        1. Objective of the test: To verify the efficiency of device.

        2. Test methods and procedures: Clinical test in two positions: Seated and Supine.

        3. DUT: Transtek Wrist Blood Pressure Monitor, Model: TMB-1117. Cuff size: 13.5 - 21.5 cm.

        4. Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and
           range: 0-300 mmHg.

        5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.

        6. Statistical methodology used: Description of statistical methods.

        7. Result: Meet the requirements of SP10.
Hospital Information

      Hospital Information The data was collected by Zhongshan City People's Hospital Clinical
      Investigator Team at Zhongshan City People's Hospital, No.2 Sunwen Dong Road, Zhongshan,
      Guangdong 528403, P. R. China.

      Investigator: Dr. Cao Yuedong, Leader; Li Qidong, Nurse A; Chen Wenqian, Nurse B.

      Contact Dr. Cao Yuedong Tel: +86 760 88823818

      Used Equipments DUT (Device Under Test): Transtek Wrist Blood Pressure Monitor, TMB-1117
      Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and range:
      0-300 mmHg.

      Test Protocol

        1. Test Purpose:

           The aim of clinical test is to determine, for the purpose of design qualification, the
           overall performance of the system meeting the following requirement: For systolic and
           diastolic pressures, treated separately, the mean difference of the paired measurement
           of the test system and the comparison system shall be ± 5 mmHg or less, with standard
           deviation of 8 mmHg or less.

        2. Target Subject:

      1) The subject database shall contain at least 85 subjects. 2) The distribution of blood
      pressure of the subjects required to be: At least 10 percent below 100 mmHg systolic; at
      least 10 percent above 160 mmHg systolic; at least 10 percent below 60 mmHg diastolic; at
      least 10 percent above 100 mmHg diastolic; with the remainder distributed between these outer
      limits.

      3. Identification and precision of equipment used According to ANSI/AAMI SP10, the maximum
      measurement error of the non-automatic sphygmomanometers used in the comparing test shall not
      exceed 1.0mmHg at the temperature of the test. The manometer was used to verify its accuracy
      before test.

      The clinical study was conducted according to the protocol described in the ANSI/AAMI SP10
      with 85 subjects.

      4. Test procedures (auscultatory method, same-limb sequential measurement was chosen)

        1. Record the age, gender, and circumference of the left wrist of the subject.

        2. Let subject seated or supine calmly for five minutes before test.

        3. Measure heart rate in one minute by palpation on radial artery, record it.

        4. Two observers shall make simultaneous, blinded, blood pressure determination on the
           subject's left arm. Each nurse will write down the reading on a small piece of paper,
           make a tick if there is an auscultatory gap and then submit to the recorder.

        5. The two readings separately from two observers will be recorded, and if two observers
           agree that they find an auscultatory gap this time, it will also be recorded. The wrist
           cuff will be take off, after 90 seconds rest, TMB-1117 cuff will be taken on and tested,
           and the readings (systolic, diastolic, mean BP and Heart rate) be recorded.

        6. For each subject, repeat 3) and 5) to get 3 measurements.

        7. Repeat step 1) to 6) for every subject.

      5. Note:

        1. No motion and speaking are allowed during the measurement.

        2. The reference device's cuff release at the rate about 3 mmHg/s so to ensure an accurate
           reading of observer.

        3. The arm, wrist and the haear of subject to keep on the same height when measurement.

        4. Test environment: Temperature: 20±1 ℃; Relative humidity: 40~50%.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Verify the accuracy of measure functions of device
time frame: 10 days
description: Verify the accuracy of device if meet the requirements of ANSI/AAMI SP10 when it measure Systolic & Diastolic blood pressure.
arm group label: DUT Arm
arm group type: Experimental
description: DUT: Transtek Wrist Blood Pressure Monitor TMB-1117
Measurement: Blood Pressure
Groups/Cohorts: DUT
arm group label: Reference Arm
arm group type: Experimental
description: Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1mmHg and range: 0-300mmHg.
Measurement: Blood Pressure
Groups/Cohorts: Reference
intervention type: Device
intervention name: Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117
description: Systolic, Diastolic pressure.
arm group label: DUT Arm
other name: DUT TMB-1117 measurement
intervention type: Device
intervention name: Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2
description: Systolic, Diastolic pressure
arm group label: Reference Arm
other name: Reference mercury sphygmomanometer measurement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Leo Wang, Leader
role: Study Chair
affiliation: BTS International
facility: 
country: China
url: http://www.zsph.com
description: Related Info
citation: Alpert BS. Validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitor to the ISO Standard and BHS protocol. Blood Press Monit. 2010 Oct;15(5):275-7. doi: 10.1097/MBP.0b013e32833c8b39.
PMID: 20559140
responsible party type: Sponsor-Investigator
investigator affiliation: BTS International
investigator full name: Leo Wang
investigator title: Team leader
mesh term: Hypertension