<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/NCT03008980</url>
  </required_header>
  <id_info>
    <org_study_id>CDx 103</org_study_id>
    <nct_id>NCT03008980</nct_id>
  </id_info>
  <brief_title>WATS3D for the Detection of Esophageal Dysplasia</brief_title>
  <official_title>Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Analysis (WATS) for the Detection of Esophageal Dysplasia: A Prospective, Randomized, Tandem Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CDx Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rockford Gastroenterology Associates</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CDx Diagnostics</source>
  <brief_summary>
    <textblock>
      Patients will be recruited from participating institutions prior to planned routine care EGD&#xD;
      with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who&#xD;
      are potentially eligible for the study will be approached regarding the study. If interested,&#xD;
      participants will be consented and proceed with routine care EGD. The study coordinator or&#xD;
      other research personnel will document information from the routine care endoscopy as part of&#xD;
      this research study. Follow-up information collected will include WATS3D cytology and forceps&#xD;
      biopsy pathology results from any routine care endoscopy performed during the course of&#xD;
      participation in the study, any surgeries received and related to their condition, and any&#xD;
      other care received as part of their condition. WATS3D samples will be sent to CDx&#xD;
      Diagnostics for analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Outcomes of patients undergoing WATS sampling. Specifically incremental yield for Barrett's Esophagus and Esophageal Dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings.</measure>
    <time_frame>up to 18 years</time_frame>
  </primary_outcome>
  <number_of_groups>7</number_of_groups>
  <enrollment type="Actual">160</enrollment>
  <condition>Barrett Esophagus</condition>
  <condition>Esophageal Dysplasia</condition>
  <condition>Esophagus Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Community GI Group</arm_group_label>
    <description>Diagnostic Test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Academic GI Group</arm_group_label>
    <description>Diagnostic Test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Academic Esophageal Dysplasia and Cancer</arm_group_label>
    <description>Diagnostic Test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community Barrett's Esophagus Screening</arm_group_label>
    <description>Diagnostic Test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community Esophageal Dysplasia</arm_group_label>
    <description>Diagnostic Test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-Ablation BE and Esophagus Dysplasia</arm_group_label>
    <description>Diagnostic Test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GERD, BE, and Esophageal Dysplasia</arm_group_label>
    <description>Diagnostic Test</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diagnostic Test</intervention_name>
    <arm_group_label>Academic Esophageal Dysplasia and Cancer</arm_group_label>
    <arm_group_label>Academic GI Group</arm_group_label>
    <arm_group_label>Community Barrett's Esophagus Screening</arm_group_label>
    <arm_group_label>Community Esophageal Dysplasia</arm_group_label>
    <arm_group_label>Community GI Group</arm_group_label>
    <arm_group_label>GERD, BE, and Esophageal Dysplasia</arm_group_label>
    <arm_group_label>Post-Ablation BE and Esophagus Dysplasia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with known Barrett's Esophagus.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age: ≥ 18 years&#xD;
&#xD;
          -  Patients should have a history of Barrett's esophagus (with or without dysplasia of&#xD;
             either indefinite, low grade or high-grade)&#xD;
&#xD;
          -  Willingness to undergo both WATS and forceps biopsies while undergoing conventional&#xD;
             EGD with sedation&#xD;
&#xD;
          -  Ability to provide written, informed consent (approved by IRB) and understand the&#xD;
             responsibilities of trial participation&#xD;
&#xD;
          -  Only patients who undergo both forceps biopsies and WATS of the esophagus will be&#xD;
             included in this study&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Coagulopathy with an international normalized ratio above 2.0;&#xD;
&#xD;
          -  Thrombocytopenia with platelet counts below 50,000&#xD;
&#xD;
          -  History of prior esophageal ablation therapies, esophageal or gastric surgery&#xD;
&#xD;
          -  Unresolved drug or alcohol dependency&#xD;
&#xD;
          -  Pregnancy or planned pregnancy during the study period&#xD;
&#xD;
          -  Patients found to have a BE length less than 1 cm or greater than 10 cm&#xD;
&#xD;
          -  Patients with any visible lesions greater than 10 mm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mike Smith</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>October 27, 2021</last_update_submitted>
  <last_update_submitted_qc>October 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2021</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>
  </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/NCT03008980
org study id: CDx 103
nct id: NCT03008980
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
Patients will be recruited from participating institutions prior to planned routine care EGD
      with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who
      are potentially eligible for the study will be approached regarding the study. If interested,
      participants will be consented and proceed with routine care EGD. The study coordinator or
      other research personnel will document information from the routine care endoscopy as part of
      this research study. Follow-up information collected will include WATS3D cytology and forceps
      biopsy pathology results from any routine care endoscopy performed during the course of
      participation in the study, any surgeries received and related to their condition, and any
      other care received as part of their condition. WATS3D samples will be sent to CDx
      Diagnostics for analysis.
observational model: Cohort
time perspective: Cross-Sectional
measure: Outcomes of patients undergoing WATS sampling. Specifically incremental yield for Barrett's Esophagus and Esophageal Dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings.
time frame: up to 18 years
arm group label: Community GI Group
description: Diagnostic Test
arm group label: Academic GI Group
description: Diagnostic Test
arm group label: Academic Esophageal Dysplasia and Cancer
description: Diagnostic Test
arm group label: Community Barrett's Esophagus Screening
description: Diagnostic Test
arm group label: Community Esophageal Dysplasia
description: Diagnostic Test
arm group label: Post-Ablation BE and Esophagus Dysplasia
description: Diagnostic Test
arm group label: GERD, BE, and Esophageal Dysplasia
description: Diagnostic Test
intervention type: Other
intervention name: Diagnostic Test
arm group label: Academic Esophageal Dysplasia and Cancer
arm group label: Academic GI Group
arm group label: Community Barrett's Esophagus Screening
arm group label: Community Esophageal Dysplasia
arm group label: Community GI Group
arm group label: GERD, BE, and Esophageal Dysplasia
arm group label: Post-Ablation BE and Esophagus Dysplasia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Barrett Esophagus