<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/NCT02988934</url>
  </required_header>
  <id_info>
    <org_study_id>CDx 707</org_study_id>
    <nct_id>NCT02988934</nct_id>
  </id_info>
  <brief_title>The WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) U.S. Registry</brief_title>
  <official_title>The WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) U.S. Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CDx Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CDx Diagnostics</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to create a registry (collect data and keep it in a research&#xD;
      database) to learn more about two methods of taking small tissue samples from your esophagus&#xD;
      (the esophagus is the tube that carries food and liquid from your mouth to your stomach.).&#xD;
      The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples)&#xD;
      from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.&#xD;
&#xD;
      By recording the results of all of your biopsies over many years, it may be possible to find&#xD;
      out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn&#xD;
      develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and&#xD;
      which patients with Barrett's esophagus develop precancer and cancer. The data from your&#xD;
      biopsies will be used to determine the best way to diagnose esophageal disease.&#xD;
&#xD;
      You are being asked to participate in the study because you are receiving an upper endoscopy&#xD;
      (a procedure where a tube with a light and camera are inserted in your mouth and down your&#xD;
      throat) with forceps and brush biopsies of your esophagus as part of your standard clinical&#xD;
      care, and you are between the ages of 18 and 80.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">February 7, 2023</completion_date>
  <primary_completion_date type="Actual">February 7, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Incremental yield for dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings.</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Outcomes of patients undergoing WATS sampling.</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">3173</enrollment>
  <condition>Barrett Esophagus</condition>
  <condition>Gastroesophageal Reflux</condition>
  <condition>Esophageal Dysplasia</condition>
  <condition>Esophageal Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        males and females&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Able to read, comprehend, and complete the consent form&#xD;
&#xD;
          -  Aged 18 to 80, and,&#xD;
&#xD;
          -  Meet one of the following:&#xD;
&#xD;
          -  Patients with heartburn or regurgitation undergoing a screening EGD, who undergo&#xD;
             WATS3D sampling and forceps biopsies for suspicion of BE, or&#xD;
&#xD;
          -  Patients with known BE with or without dysplasia undergoing a surveillance EGD with&#xD;
             WATS3D biopsies and forceps biopsies, or&#xD;
&#xD;
          -  Patients who have undergone endoscopic eradication therapy(including, but not limited&#xD;
             to endoscopic mucosal resection, endoscopic submucosal dissection, radiofrequency&#xD;
             ablation and/orcryoablation/spray cryotherapy)who are undergoing surveillance EGD&#xD;
             following the establishment of complete eradication of intestinal metaplasia (CEIM)&#xD;
             with accompanying WATS3D sampling and forceps biopsies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients meeting any of the following criteria will be excluded from this study:&#xD;
&#xD;
          -  Patients who on their enrollment endoscopy have a visible highly suspicious lesion,&#xD;
             such as a nodule or ulcer, (noted while undergoing endoscopy) that requires targeted&#xD;
             biopsy will be excluded from the study.Patients requiring a targeted biopsy on&#xD;
             follow-up endoscopies will be allowed to remain in the study.&#xD;
&#xD;
          -  Patients who do not undergo both biopsy forceps and WATS3D biopsy of the esophagus on&#xD;
             their initial evaluationfor routine care will be excluded from this study. Subsequent&#xD;
             endoscopicevaluation may include forceps biopsies alone, WATS3D biopsies alone, or&#xD;
             both forceps and WATS3D biopsies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Barrett Esophagus</mesh_term>
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Esophageal Diseases</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/NCT02988934
org study id: CDx 707
nct id: NCT02988934
lead sponsor: 
collaborator: 
The purpose of this study is to create a registry (collect data and keep it in a research
      database) to learn more about two methods of taking small tissue samples from your esophagus
      (the esophagus is the tube that carries food and liquid from your mouth to your stomach.).
      The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples)
      from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.

      By recording the results of all of your biopsies over many years, it may be possible to find
      out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn
      develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and
      which patients with Barrett's esophagus develop precancer and cancer. The data from your
      biopsies will be used to determine the best way to diagnose esophageal disease.

      You are being asked to participate in the study because you are receiving an upper endoscopy
      (a procedure where a tube with a light and camera are inserted in your mouth and down your
      throat) with forceps and brush biopsies of your esophagus as part of your standard clinical
      care, and you are between the ages of 18 and 80.
observational model: Cohort
time perspective: Prospective
measure: Incremental yield for dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings.
time frame: 10 years
measure: Outcomes of patients undergoing WATS sampling.
time frame: 10 years
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Barrett Esophagus
mesh term: Gastroesophageal Reflux
mesh term: Esophageal Diseases