<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/NCT03015389</url>
  </required_header>
  <id_info>
    <org_study_id>CDx 810</org_study_id>
    <nct_id>NCT03015389</nct_id>
  </id_info>
  <brief_title>Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D) For the Detection of High Grade Esophageal Dysplasia and Adenocarcinoma</brief_title>
  <official_title>Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D) For the Detection of High Grade Esophageal Dysplasia and Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CDx Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CDx Diagnostics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, prospective, randomized study which will enroll patients undergoing&#xD;
      endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of&#xD;
      the research team will approach a potential subject to discuss participation in the study,&#xD;
      including background of the proposed study, inclusion and exclusion criteria, benefits and&#xD;
      risks of the procedures and follow-up. If this is of interest to the subject, the informed&#xD;
      consent form is discussed and presented. The subject must sign the consent form prior to&#xD;
      enrollment. This form will have prior approval of the study site's Institutional Review Board&#xD;
      (IRB). Failure to obtain informed consent renders the subject ineligible for the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2017</start_date>
  <completion_date type="Actual">February 18, 2019</completion_date>
  <primary_completion_date type="Actual">February 18, 2019</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>Detection rate of Barrett's associated high grade esophageal dysplasia and esophageal adenocarcinoma (HGD/EAC) using WATS3D and random 4 quadrant forceps biopsies taken at 2 cm intervals.</measure>
    <time_frame>up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Barrett's related dysplasia and adenocarcinoma diagnosed with random forceps biopsies and WATS3D biopsies used in alternating fashion.</measure>
    <time_frame>up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">170</enrollment>
  <condition>Barrett Esophagus</condition>
  <condition>Esophageal Dysplasia</condition>
  <condition>Esophageal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Barrett's associated esophageal dysplasia</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Diagnostic Test</intervention_name>
    <description>WATS3D brush biopsy</description>
    <arm_group_label>Barrett's associated esophageal dysplasia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Barrett's associated esophageal dysplasia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients age: ≥ 18 years&#xD;
&#xD;
          2. Patients should have a history of Barrett's associated esophageal dysplasia (either&#xD;
             low or high-grade) confirmed on histology&#xD;
&#xD;
          3. Willingness to undergo both WATS3D and random forceps biopsies while undergoing&#xD;
             conventional EGD with sedation&#xD;
&#xD;
          4. Ability to provide written, informed consent (approved by IRB) and understand the&#xD;
             responsibilities of trial participation&#xD;
&#xD;
          5. Only patients who no visible mucosal abnormalities at the time that they undergo both&#xD;
             random forceps biopsies and WATS3D testing of the esophagus will be included in this&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Coagulopathy with INR &gt; 2.0, thrombocytopenia with platelet counts &lt; 50,000&#xD;
&#xD;
          2. The subject is pregnant or planning a pregnancy during the study period&#xD;
&#xD;
          3. History of esophageal or gastric surgery other than Endoscopic Mucosal Resection (EMR)&#xD;
&#xD;
          4. Patients who have undergone endoscopic ablative therapies&#xD;
&#xD;
          5. Subject has a known history of unresolved drug or alcohol dependency that would limit&#xD;
             ability to comprehend or follow instructions related to informed consent,&#xD;
             post-treatment instructions, or follow-up guidelines&#xD;
&#xD;
          6. Study patients with inadequate WATS3D specimens will not undergo a repeat brush biopsy&#xD;
             test and will be excluded from the study&#xD;
&#xD;
          7. BE length &lt; 1 cm or &gt; 10 cm&#xD;
&#xD;
          8. Patients within six weeks of receiving targeted forceps biopsies and/or EMR&#xD;
&#xD;
          9. Patients with visible mucosal abnormality at the time of the WATS3D and random biopsy&#xD;
             testing&#xD;
&#xD;
         10. Patients with visible lesions that are either submucosal or covered with a clinically&#xD;
             intact epithelium&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raf Bisschops, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Leuven, Dept. of Gastroenterology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cesare Hassan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nuovo Regina Margherita Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven - Campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</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>Adenocarcinoma</mesh_term>
    <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/NCT03015389
org study id: CDx 810
nct id: NCT03015389
lead sponsor: 
has dmc: No
This is a multi-center, prospective, randomized study which will enroll patients undergoing
      endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of
      the research team will approach a potential subject to discuss participation in the study,
      including background of the proposed study, inclusion and exclusion criteria, benefits and
      risks of the procedures and follow-up. If this is of interest to the subject, the informed
      consent form is discussed and presented. The subject must sign the consent form prior to
      enrollment. This form will have prior approval of the study site's Institutional Review Board
      (IRB). Failure to obtain informed consent renders the subject ineligible for the study.
observational model: Cohort
time perspective: Cross-Sectional
measure: Detection rate of Barrett's associated high grade esophageal dysplasia and esophageal adenocarcinoma (HGD/EAC) using WATS3D and random 4 quadrant forceps biopsies taken at 2 cm intervals.
time frame: up to 2 years
measure: Number of participants with Barrett's related dysplasia and adenocarcinoma diagnosed with random forceps biopsies and WATS3D biopsies used in alternating fashion.
time frame: up to 2 years
arm group label: Barrett's associated esophageal dysplasia
intervention type: Procedure
intervention name: Diagnostic Test
description: WATS3D brush biopsy
arm group label: Barrett's associated esophageal dysplasia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raf Bisschops, MD
role: Principal Investigator
affiliation: University Hospitals Leuven, Dept. of Gastroenterology
last name: Cesare Hassan, MD
role: Principal Investigator
affiliation: Nuovo Regina Margherita Hospital
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Barrett Esophagus