<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/NCT02994693</url>
  </required_header>
  <id_info>
    <org_study_id>2016-P000919</org_study_id>
    <secondary_id>5R01CA184102-02</secondary_id>
    <nct_id>NCT02994693</nct_id>
  </id_info>
  <brief_title>Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy</brief_title>
  <official_title>Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research is to determine the natural history of Barrett's esophagus (BE)&#xD;
      using tethered capsule endomicroscopy (TCE) in patients undergoing surveillance endoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MGH will be the first site in the multi-center study to begin enrolling. At the MGH 100&#xD;
      subjects with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled.&#xD;
&#xD;
      Each subject will undergo a minimum of 2 esophagogastroduodenoscopies (EGD), one around the&#xD;
      time of inclusion into the study and one at the end of the study, and 4 TCE imaging sessions&#xD;
      (baseline, 1-year, 2-years and at the end of the 3-years follow-up). If it is determined by&#xD;
      the treating physician that additional EGDs are needed, for extended follow-up or treatment,&#xD;
      capsule imaging will be performed whenever possible.&#xD;
&#xD;
      Patients will have received written information prior to the day of the capsule procedure and&#xD;
      patients will have another chance to discuss the procedure with the study coordinator and&#xD;
      clinical study staff during the consent process prior to the capsule procedure. Participation&#xD;
      in this study is completely voluntary, and the patient can stop the procedure at any time.&#xD;
&#xD;
      For each of the imaged patients, inclusion criteria and clinical characteristics such as age,&#xD;
      sex, body mass index (BMI), current medication regimen, smoking history and GI related&#xD;
      history will be recorded in the clinical form.&#xD;
&#xD;
      Subjects will be seated and asked to sip water to facilitate swallowing the capsule.&#xD;
&#xD;
      The device will be operated by experienced study staff trained in the procedure such as a&#xD;
      registered nurse or one of the endoscopist co-investigators in this study. Emergency phone&#xD;
      and/or pager contact of the collaborating GI clinician(s) will be provided. They will also be&#xD;
      accessible during the procedure if any problems are encountered that require their expertise.&#xD;
&#xD;
      Imaging will be performed in the same manner as in our other current IRB approved tethered&#xD;
      capsule endomicroscopy studies. The capsule position will be controlled manually via the&#xD;
      tether outside of the subject's mouth by the catheter operator. Recorded real-time&#xD;
      cross-sectional images displayed on the monitor and distance marks on the tether will be used&#xD;
      for confirmation of capsule position in the esophagus. Images will be viewed in real time to&#xD;
      determine when the capsule has reached the stomach. The resistance of the tether can also&#xD;
      give information of the cardia position. Once in the stomach, the capsule will be gradually&#xD;
      pulled back up through the esophagus to the mouth, also while imaging. The capsule may be&#xD;
      repositioned for imaging up to 4 times up and 4 times down the esophagus. The subject may be&#xD;
      asked to swallow a different size capsule (ranging from 5-12.8 mm in diameter and 20-30 cm in&#xD;
      length) to obtain the best distal esophageal images. It is expected that the maximum&#xD;
      experimental time including swallowing the capsule, the imaging procedure, and removal of the&#xD;
      capsule will take approximately 10 minutes in total.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Longitudinal assessment of the Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy</measure>
    <time_frame>Approximate 25 minutes visit (10 min image acquisition)</time_frame>
    <description>An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. They will assess how the images change over time.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Barrett Esophagus</condition>
  <condition>Barretts Esophagus With Dysplasia</condition>
  <arm_group>
    <arm_group_label>OFDI capsule imaging</arm_group_label>
    <description>Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OFDI capsule imaging</intervention_name>
    <description>Imaging of Barrett's esophagus (BE) using OFDI capsule imaging</description>
    <arm_group_label>OFDI capsule imaging</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with known BE without high grade dysplasia, intramucosal adenocarcinoma or&#xD;
        esophageal adenocarcinoma, confirmed by endoscopic biopsy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with known BE without high grade dysplasia, intramucosal adenocarcinoma or&#xD;
             esophageal adenocarcinoma, confirmed by endoscopic biopsy,&#xD;
&#xD;
          -  Patients over the age of 18&#xD;
&#xD;
          -  Patients who are capable of giving informed consent&#xD;
&#xD;
          -  Patients who had or will have a standard of care EGD within 9 to 15 months&#xD;
&#xD;
          -  Subjects must have no solid food for at least 4 hours prior to the procedure, and only&#xD;
             clear liquids for 2 hours prior to the procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with prior endoscopic ablation or resection treatment of BE&#xD;
&#xD;
          -  Patients with esophageal fistula and/or esophageal strictures with a luminal stricture&#xD;
             diameter that is smaller than the diameter of the capsule&#xD;
&#xD;
          -  Patients with the inability to swallow capsules.&#xD;
&#xD;
          -  Pregnancy, according to patient information&#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>Guillermo Tearney, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anna Gao, RN</last_name>
    <phone>617-643-6092</phone>
    <email>Tearneylabtrials@partners.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anita Chung, RN</last_name>
    <phone>617-724-4515</phone>
    <email>Tearneylabtrials@partners.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Gao, RN</last_name>
      <phone>617-643-6092</phone>
      <email>Tearneylabtrials@partners.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 13, 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>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Guillermo Tearney</investigator_full_name>
    <investigator_title>Principal Investigator - MD, PhD, FACC, FCAP, FNAI</investigator_title>
  </responsible_party>
  <keyword>Barrett's Esophagus</keyword>
  <keyword>Natural History</keyword>
  <keyword>Device</keyword>
  <keyword>OCT</keyword>
  <keyword>Capsule</keyword>
  <keyword>Tethered Capsule Endomicroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Barrett Esophagus</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/NCT02994693
org study id: 2016-P000919
secondary id: 5R01CA184102-02
nct id: NCT02994693
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The goal of this research is to determine the natural history of Barrett's esophagus (BE)
      using tethered capsule endomicroscopy (TCE) in patients undergoing surveillance endoscopy.
The MGH will be the first site in the multi-center study to begin enrolling. At the MGH 100
      subjects with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled.

      Each subject will undergo a minimum of 2 esophagogastroduodenoscopies (EGD), one around the
      time of inclusion into the study and one at the end of the study, and 4 TCE imaging sessions
      (baseline, 1-year, 2-years and at the end of the 3-years follow-up). If it is determined by
      the treating physician that additional EGDs are needed, for extended follow-up or treatment,
      capsule imaging will be performed whenever possible.

      Patients will have received written information prior to the day of the capsule procedure and
      patients will have another chance to discuss the procedure with the study coordinator and
      clinical study staff during the consent process prior to the capsule procedure. Participation
      in this study is completely voluntary, and the patient can stop the procedure at any time.

      For each of the imaged patients, inclusion criteria and clinical characteristics such as age,
      sex, body mass index (BMI), current medication regimen, smoking history and GI related
      history will be recorded in the clinical form.

      Subjects will be seated and asked to sip water to facilitate swallowing the capsule.

      The device will be operated by experienced study staff trained in the procedure such as a
      registered nurse or one of the endoscopist co-investigators in this study. Emergency phone
      and/or pager contact of the collaborating GI clinician(s) will be provided. They will also be
      accessible during the procedure if any problems are encountered that require their expertise.

      Imaging will be performed in the same manner as in our other current IRB approved tethered
      capsule endomicroscopy studies. The capsule position will be controlled manually via the
      tether outside of the subject's mouth by the catheter operator. Recorded real-time
      cross-sectional images displayed on the monitor and distance marks on the tether will be used
      for confirmation of capsule position in the esophagus. Images will be viewed in real time to
      determine when the capsule has reached the stomach. The resistance of the tether can also
      give information of the cardia position. Once in the stomach, the capsule will be gradually
      pulled back up through the esophagus to the mouth, also while imaging. The capsule may be
      repositioned for imaging up to 4 times up and 4 times down the esophagus. The subject may be
      asked to swallow a different size capsule (ranging from 5-12.8 mm in diameter and 20-30 cm in
      length) to obtain the best distal esophageal images. It is expected that the maximum
      experimental time including swallowing the capsule, the imaging procedure, and removal of the
      capsule will take approximately 10 minutes in total.
observational model: Cohort
time perspective: Prospective
measure: Longitudinal assessment of the Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
time frame: Approximate 25 minutes visit (10 min image acquisition)
description: An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. They will assess how the images change over time.
arm group label: OFDI capsule imaging
description: Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.
intervention type: Device
intervention name: OFDI capsule imaging
description: Imaging of Barrett's esophagus (BE) using OFDI capsule imaging
arm group label: OFDI capsule imaging
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guillermo Tearney, MD, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Anna Gao, RN
phone: 617-643-6092
email: Tearneylabtrials@partners.org
last name: Anita Chung, RN
phone: 617-724-4515
email: Tearneylabtrials@partners.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Guillermo Tearney
investigator title: Principal Investigator - MD, PhD, FACC, FCAP, FNAI
mesh term: Barrett Esophagus
sharing ipd: No