<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/NCT03014739</url>
  </required_header>
  <id_info>
    <org_study_id>ME1</org_study_id>
    <nct_id>NCT03014739</nct_id>
  </id_info>
  <brief_title>Evaluation of Shear Wave Elastography Reproducibility in Achilles Tendons and Plantar Fascia</brief_title>
  <acronym>ME1</acronym>
  <official_title>Evaluation of the Reproducibility of Young's Modulus and Shear Wave Velocity Measurements With SWE™ in Achilles Tendons and Plantar Fascia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SuperSonic Imagine</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>SuperSonic Imagine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Achilles tendon plays a significant role in walking and sporting activities, particularly&#xD;
      through ankle joint and lower limbs stability. Ultrasound imaging can be the first-line&#xD;
      examination of choice for patients suspected of having Achilles tendon injury, which is more&#xD;
      and more frequent. Nowadays, ultrasound elastography can be used to evaluate the&#xD;
      viscoelasticity properties of Achilles tendon, however little is known about the&#xD;
      reproducibility of the technique. This study aims to evaluate the reproducibility of&#xD;
      supersonic shear imaging SWE™ Young's modulus measurements of shear wave velocity (m/s) in&#xD;
      Achilles tendon and plantar fascia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intra- and inter-operator reproducibility</measure>
    <time_frame>Baseline</time_frame>
    <description>Intraclass Correlation Coefficient</description>
  </primary_outcome>
  <other_outcome>
    <measure>Effect of limb dominance</measure>
    <time_frame>Baseline</time_frame>
    <description>Variability of ICC as a function of dominant versus non-dominant leg</description>
  </other_outcome>
  <enrollment type="Actual">1165</enrollment>
  <condition>Achilles Tendon</condition>
  <condition>Plantar Fascia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supersonic ShearWave Elastography</intervention_name>
    <description>ShearWave Elastography (SWE) is part of routine ultrasound examination</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers without any Achilles tendon disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteers with normal Achilles tendon:&#xD;
&#xD;
          -  Normal adult aged over 18 years old;&#xD;
&#xD;
          -  Without lower limb malformation;&#xD;
&#xD;
          -  With no symptoms of Achilles tendon lesion and no negative results of routine&#xD;
             ultrasound examination for a possible tendinopathy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who failed to meet all inclusion criteria were will be automatically&#xD;
             excluded;&#xD;
&#xD;
          -  Subjects who did will not wish or could will not sign the informed consent in person.&#xD;
&#xD;
          -  Volunteers with abnormal Achilles tendon for any of these reasons:&#xD;
&#xD;
               -  Lower limb malformation;&#xD;
&#xD;
               -  Achilles tendon pain, Achilles tendon disease, surgical history of Achilles&#xD;
                  tendon surgery, morphologic abnormalities of Achilles tendon ( gray-scale/color&#xD;
                  Doppler/MRI/plain film);&#xD;
&#xD;
               -  Suffer from systemic, metabolic and endocrine diseases, including but not limited&#xD;
                  to, diabetes, familial hyperlipidemia (FH), systemic lupus erythematosus (SLE),&#xD;
                  gout, ankylosing spondylitis, hyperthyroidism, chronic renal failure, etc.&#xD;
&#xD;
               -  Pregnant women;&#xD;
&#xD;
               -  Apply Ongoing hormone hormonal therapy;&#xD;
&#xD;
               -  Athletes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Chao-Yang Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The third Affiliated Hospital of Peking University</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Cao W, Sun Y, Liu L, Wang Z, Wu JY, Qiu L, Wang YX, Yuan Y, Shen SF, Chen Q, Chen T, Zhang W, Wu CJ, Liu FX, Zhong SG, Chen L, Tong MH, Cui LG, Guo RJ. A Multicenter Large-Sample Shear Wave Ultrasound Elastographic Study of the Achilles Tendon in Chinese Adults. J Ultrasound Med. 2019 May;38(5):1191-1200. doi: 10.1002/jum.14797. Epub 2018 Sep 12.</citation>
    <PMID>30208234</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Elastography</keyword>
  <keyword>Musculoskeletal System</keyword>
  <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/NCT03014739
org study id: ME1
nct id: NCT03014739
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Achilles tendon plays a significant role in walking and sporting activities, particularly
      through ankle joint and lower limbs stability. Ultrasound imaging can be the first-line
      examination of choice for patients suspected of having Achilles tendon injury, which is more
      and more frequent. Nowadays, ultrasound elastography can be used to evaluate the
      viscoelasticity properties of Achilles tendon, however little is known about the
      reproducibility of the technique. This study aims to evaluate the reproducibility of
      supersonic shear imaging SWE™ Young's modulus measurements of shear wave velocity (m/s) in
      Achilles tendon and plantar fascia.
observational model: Cohort
time perspective: Prospective
measure: Intra- and inter-operator reproducibility
time frame: Baseline
description: Intraclass Correlation Coefficient
measure: Effect of limb dominance
time frame: Baseline
description: Variability of ICC as a function of dominant versus non-dominant leg
intervention type: Other
intervention name: Supersonic ShearWave Elastography
description: ShearWave Elastography (SWE) is part of routine ultrasound examination
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: China
citation: Cao W, Sun Y, Liu L, Wang Z, Wu JY, Qiu L, Wang YX, Yuan Y, Shen SF, Chen Q, Chen T, Zhang W, Wu CJ, Liu FX, Zhong SG, Chen L, Tong MH, Cui LG, Guo RJ. A Multicenter Large-Sample Shear Wave Ultrasound Elastographic Study of the Achilles Tendon in Chinese Adults. J Ultrasound Med. 2019 May;38(5):1191-1200. doi: 10.1002/jum.14797. Epub 2018 Sep 12.
PMID: 30208234
responsible party type: Sponsor
sharing ipd: No