<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/NCT02994797</url>
  </required_header>
  <id_info>
    <org_study_id>ELSA</org_study_id>
    <nct_id>NCT02994797</nct_id>
  </id_info>
  <brief_title>Ultrasound Elastography of Salivary Glands</brief_title>
  <acronym>ELSA</acronym>
  <official_title>Elastometry of the Salivary Glands in Sicca Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow&#xD;
      patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study&#xD;
      the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients&#xD;
      with sicca syndrome and pSS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 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>salivary glands elastometry</measure>
    <time_frame>1 day</time_frame>
    <description>Measure of elasticity of salivary glands (parotid, submandibular and sublingual) in centimeter per second</description>
  </primary_outcome>
  <enrollment type="Actual">78</enrollment>
  <condition>sjögren Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        male or female&#xD;
&#xD;
        more than 18 years old&#xD;
&#xD;
        consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  More than 18 years old&#xD;
&#xD;
          -  Consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome&#xD;
&#xD;
          -  Consent agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No consent agreement&#xD;
&#xD;
          -  No sicca symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Brest</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>salivary glands</keyword>
  <keyword>ultrasonography</keyword>
  <keyword>elastometry</keyword>
  <keyword>elastography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sjogren's Syndrome</mesh_term>
  </condition_browse>
  <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/NCT02994797
org study id: ELSA
nct id: NCT02994797
lead sponsor: 
has dmc: No
Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow
      patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study
      the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients
      with sicca syndrome and pSS.
observational model: Cohort
time perspective: Prospective
measure: salivary glands elastometry
time frame: 1 day
description: Measure of elasticity of salivary glands (parotid, submandibular and sublingual) in centimeter per second
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Sjogren's Syndrome
sharing ipd: No