<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/NCT02971527</url>
  </required_header>
  <id_info>
    <org_study_id>HJHC-YLQX2016001</org_study_id>
    <nct_id>NCT02971527</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Ultrasound Bone Strength Device to Measure Calcaneal Bone Strength Index of Human Subjects</brief_title>
  <official_title>A Multicenter, Open-Labeled, Self-Paired Study to Examine the Effectiveness and Safety of Ultrasound Bone Strength Device Used for Measuring Calcaneal Bone Strength Index of Human Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Hospital of Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Hospital of Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine whether ultrasound bone strength device (Model&#xD;
      Number: Oste-scan 500A) is effective and safe in measuring calcaneal bone strength index of&#xD;
      human subjects, compared with a listed, similar device (Model Number: SONOST3000).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study adopt a method of multicenter, open-labeled, self-paired design. Each subject will&#xD;
      be randomly assigned to two different detective sequence groups. In one group, the&#xD;
      investigators will detect the same calcaneus of each subject by experimental ultrasound bone&#xD;
      strength device firstly and then by control device. In another group, the investigators will&#xD;
      detect the same calcaneus of each subject by control ultrasound bone strength device firstly&#xD;
      and then by experimental device. Experimental ultrasound bone strength device is developed by&#xD;
      Wuxi Huajian Hengchuang Medical Equipment Science and Technology Co., Ltd.. This device's&#xD;
      model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G). Control&#xD;
      ultrasound bone strength device which has same clinical indications and action mechanism with&#xD;
      the experimental one, is manufactured by Osteosys Co., Ltd.. This device's model number is&#xD;
      SONOST3000.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2017</start_date>
  <completion_date type="Actual">March 9, 2017</completion_date>
  <primary_completion_date type="Actual">March 9, 2017</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the consistent rate of bone mineral density diagnosis</measure>
    <time_frame>0-24 hours after detection</time_frame>
    <description>Calculating the consistent rate with data measured by two devices to evaluate the consistent rate of bone mineral density diagnosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the accuracy of speed of sound(SOS)</measure>
    <time_frame>After detection</time_frame>
    <description>SOS values measured by two devices will be tested by Paired T Test and Wilcoxon Signed Rank Test to evaluate the difference. In addition, calculating correlation coefficient and concordance correlation coefficient of SOS values measured by two devices to evaluate correlation and concordance of two devices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the accuracy of broadband ultrasound attenuation(BUA), stiffness(SI), T-scores and Z-scores</measure>
    <time_frame>After detection</time_frame>
    <description>Plotting monotonicity curves of BUA values, SI values, T-scores and Z-scores of two devices to evaluate the correlation of two devices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the using performance evaluation index of the device, including function, stability and convenience</measure>
    <time_frame>during detection and 0-24 hours after detection</time_frame>
    <description>Evaluating the using performance evaluation index of the device, including function, stability and convenience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vital signs, including respiration, heart rate, blood pressure and temperature</measure>
    <time_frame>before detection, during detection and 0-24 hours after detection</time_frame>
    <description>Vital signs, including respiration, heart rate, blood pressure and temperature will be observed and recorded before detection, during detection and 0-24 hours after detection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical symptoms</measure>
    <time_frame>before detection, during detection and 0-24 hours after detection</time_frame>
    <description>Clinical symptoms will be observed and recorded before detection, during detection and 0-24 hours after detection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>skin allergy caused by the device</measure>
    <time_frame>before detection, during detection and 0-24 hours after detection</time_frame>
    <description>Skin allergy caused by the device will be observed and recorded before detection, during detection and 0-24 hours after detection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of participants with adverse events</measure>
    <time_frame>in the entire trial</time_frame>
    <description>Adverse events appeared in the entire trial will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Clinical Trial</condition>
  <condition>Comparative Effectiveness Research</condition>
  <condition>Equipment Safety</condition>
  <arm_group>
    <arm_group_label>Oste-scan 500A-SONOST3000</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, the investigators will measure calcaneal bone strength index of each subject by experimental device firstly and then by control device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SONOST3000-Oste-scan 500A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, the investigators will measure calcaneal bone strength index of each subject by control device firstly and then by experimental device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oste-scan 500A</intervention_name>
    <description>The investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device. Experimental ultrasound bone strength device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G).</description>
    <arm_group_label>Oste-scan 500A-SONOST3000</arm_group_label>
    <arm_group_label>SONOST3000-Oste-scan 500A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SONOST3000</intervention_name>
    <description>The investigators will detect the same calcaneus of each subject by control ultrasound bone strength device. Control ultrasound bone strength device's model number is SONOST3000.</description>
    <arm_group_label>Oste-scan 500A-SONOST3000</arm_group_label>
    <arm_group_label>SONOST3000-Oste-scan 500A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject who need to measure calcaneal bone strength index.&#xD;
&#xD;
          -  Subject is a male or female subject 20-80 years of age.&#xD;
&#xD;
          -  Subject is willing and able to provide signed and dated written informed consent form.&#xD;
&#xD;
          -  Subject whose compliance is good and can cooperate to complete the clinical trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject whose heel skin fester or defect.&#xD;
&#xD;
          -  Subject has a history of allergic reactions to ultrasonic coupling agent.&#xD;
&#xD;
          -  Subject who is not cooperative obviously or nervous extremely.&#xD;
&#xD;
          -  Pregnant or lactating females.&#xD;
&#xD;
          -  Subject has a mental disease, without self-control.&#xD;
&#xD;
          -  Subject has participated in other clinical trial within a month.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huijie Zhang, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Office Director of Clinical Trial Institution</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>April 12, 2017</last_update_submitted>
  <last_update_submitted_qc>April 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Second Hospital of Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Zhang Hui Jie</investigator_full_name>
    <investigator_title>Office Director of Clinical Trial Institution</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 27, 2018</submitted>
    <submission_canceled>July 4, 2018</submission_canceled>
    <submitted>July 4, 2018</submitted>
    <returned>January 10, 2019</returned>
  </pending_results>
  <!-- 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/NCT02971527
org study id: HJHC-YLQX2016001
nct id: NCT02971527
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine whether ultrasound bone strength device (Model
      Number: Oste-scan 500A) is effective and safe in measuring calcaneal bone strength index of
      human subjects, compared with a listed, similar device (Model Number: SONOST3000).
This study adopt a method of multicenter, open-labeled, self-paired design. Each subject will
      be randomly assigned to two different detective sequence groups. In one group, the
      investigators will detect the same calcaneus of each subject by experimental ultrasound bone
      strength device firstly and then by control device. In another group, the investigators will
      detect the same calcaneus of each subject by control ultrasound bone strength device firstly
      and then by experimental device. Experimental ultrasound bone strength device is developed by
      Wuxi Huajian Hengchuang Medical Equipment Science and Technology Co., Ltd.. This device's
      model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G). Control
      ultrasound bone strength device which has same clinical indications and action mechanism with
      the experimental one, is manufactured by Osteosys Co., Ltd.. This device's model number is
      SONOST3000.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: the consistent rate of bone mineral density diagnosis
time frame: 0-24 hours after detection
description: Calculating the consistent rate with data measured by two devices to evaluate the consistent rate of bone mineral density diagnosis.
measure: the accuracy of speed of sound(SOS)
time frame: After detection
description: SOS values measured by two devices will be tested by Paired T Test and Wilcoxon Signed Rank Test to evaluate the difference. In addition, calculating correlation coefficient and concordance correlation coefficient of SOS values measured by two devices to evaluate correlation and concordance of two devices.
measure: the accuracy of broadband ultrasound attenuation(BUA), stiffness(SI), T-scores and Z-scores
time frame: After detection
description: Plotting monotonicity curves of BUA values, SI values, T-scores and Z-scores of two devices to evaluate the correlation of two devices.
measure: the using performance evaluation index of the device, including function, stability and convenience
time frame: during detection and 0-24 hours after detection
description: Evaluating the using performance evaluation index of the device, including function, stability and convenience.
measure: vital signs, including respiration, heart rate, blood pressure and temperature
time frame: before detection, during detection and 0-24 hours after detection
description: Vital signs, including respiration, heart rate, blood pressure and temperature will be observed and recorded before detection, during detection and 0-24 hours after detection.
measure: clinical symptoms
time frame: before detection, during detection and 0-24 hours after detection
description: Clinical symptoms will be observed and recorded before detection, during detection and 0-24 hours after detection.
measure: skin allergy caused by the device
time frame: before detection, during detection and 0-24 hours after detection
description: Skin allergy caused by the device will be observed and recorded before detection, during detection and 0-24 hours after detection.
measure: the number of participants with adverse events
time frame: in the entire trial
description: Adverse events appeared in the entire trial will be recorded.
arm group label: Oste-scan 500A-SONOST3000
arm group type: Experimental
description: In this group, the investigators will measure calcaneal bone strength index of each subject by experimental device firstly and then by control device.
arm group label: SONOST3000-Oste-scan 500A
arm group type: Experimental
description: In this group, the investigators will measure calcaneal bone strength index of each subject by control device firstly and then by experimental device.
intervention type: Device
intervention name: Oste-scan 500A
description: The investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device. Experimental ultrasound bone strength device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G).
arm group label: Oste-scan 500A-SONOST3000
arm group label: SONOST3000-Oste-scan 500A
intervention type: Device
intervention name: SONOST3000
description: The investigators will detect the same calcaneus of each subject by control ultrasound bone strength device. Control ultrasound bone strength device's model number is SONOST3000.
arm group label: Oste-scan 500A-SONOST3000
arm group label: SONOST3000-Oste-scan 500A
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Huijie Zhang, Doctor
role: Principal Investigator
affiliation: Office Director of Clinical Trial Institution
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The Second Hospital of Nanjing Medical University
investigator full name: Zhang Hui Jie
investigator title: Office Director of Clinical Trial Institution
sharing ipd: Undecided
submitted: March 27, 2018
submission canceled: July 4, 2018
submitted: July 4, 2018
returned: January 10, 2019