<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/NCT02204150</url>
  </required_header>
  <id_info>
    <org_study_id>2011P002619</org_study_id>
    <secondary_id>5R01CA103769-07</secondary_id>
    <nct_id>NCT02204150</nct_id>
  </id_info>
  <brief_title>Study to Image the Esophagus Using the OFDI Capsule</brief_title>
  <official_title>Pilot Study for Imaging of the Esophagus Using an OFDI Capsule</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this research is to test the feasibility and tolerability of the tethered&#xD;
      capsule Optical Frequency Domain Imaging (OFDI)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to&#xD;
      swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that&#xD;
      allows the capsule operator to navigate the capsule as it progresses down the esophagus using&#xD;
      natural propulsion called peristalsis as well as to bring it back up to pulled out of the&#xD;
      mouth when the procedure is done.&#xD;
&#xD;
      As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross-&#xD;
      sectional images of the esophagus are acquired.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2012</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 31, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule</measure>
    <time_frame>Images will be acquired during the OFDI imaging session which should take an average of 5 minutes</time_frame>
    <description>Number of subjects from whom the quality OFDI imaging was obtained</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Barrett's Esophagus</condition>
  <condition>Eosinophilic Esophagitis</condition>
  <arm_group>
    <arm_group_label>OFDI Capsule Imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</intervention_name>
    <description>Imaging of the esophagus using the OFDI Capsule and system</description>
    <arm_group_label>OFDI Capsule Imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A previous diagnosis of Barrett's Esophagus&#xD;
&#xD;
          -  OR a previous diagnosis of EoE&#xD;
&#xD;
          -  OR a previous diagnosis of Gastroesophageal reflux disease (GERD)&#xD;
&#xD;
          -  Subject must be 18 years or older in case of Barrett's and GERD, and over the age of&#xD;
             16 years for EoE&#xD;
&#xD;
          -  Subject must be able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with known esophageal strictures, intestinal strictures or dysphagia&#xD;
&#xD;
          -  OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillermo Tearney, MD., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>June 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>March 28, 2019</results_first_submitted>
  <results_first_submitted_qc>April 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 23, 2019</results_first_posted>
  <last_update_submitted>April 22, 2019</last_update_submitted>
  <last_update_submitted_qc>April 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2019</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</investigator_title>
  </responsible_party>
  <keyword>Optical Coherence Tomography</keyword>
  <keyword>Barrett's Esophagus</keyword>
  <keyword>Esophagus</keyword>
  <keyword>Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Barrett Esophagus</mesh_term>
    <mesh_term>Esophagitis</mesh_term>
    <mesh_term>Eosinophilic Esophagitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>In this feasibility study we try to establish the overall number of participants who are able to swallow the capsule and provide us with quality imaging using this new technology. At this point we do no distinguish tolerability separately in each of the three groups and are treating them as one.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>OFDI Capsule Imaging</title>
          <description>Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.&#xD;
OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>OFDI Capsule Imaging</title>
          <description>Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.&#xD;
OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="56"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule</title>
        <description>Number of subjects from whom the quality OFDI imaging was obtained</description>
        <time_frame>Images will be acquired during the OFDI imaging session which should take an average of 5 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OFDI Capsule Imaging</title>
            <description>Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.&#xD;
OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule</title>
          <description>Number of subjects from whom the quality OFDI imaging was obtained</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>OFDI Capsule Imaging</title>
          <description>Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.&#xD;
OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gary Tearney</name_or_title>
      <organization>Mass General Hospital</organization>
      <phone>617-724-2979</phone>
      <email>gtearney@partners.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02204150
org study id: 2011P002619
secondary id: 5R01CA103769-07
nct id: NCT02204150
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The main purpose of this research is to test the feasibility and tolerability of the tethered
      capsule Optical Frequency Domain Imaging (OFDI)
A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to
      swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that
      allows the capsule operator to navigate the capsule as it progresses down the esophagus using
      natural propulsion called peristalsis as well as to bring it back up to pulled out of the
      mouth when the procedure is done.

      As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross-
      sectional images of the esophagus are acquired.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule
time frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
description: Number of subjects from whom the quality OFDI imaging was obtained
arm group label: OFDI Capsule Imaging
arm group type: Experimental
description: Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.
intervention type: Device
intervention name: OFDI Capsule
description: Imaging of the esophagus using the OFDI Capsule and system
arm group label: OFDI Capsule Imaging
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Guillermo Tearney, MD., PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Guillermo Tearney
investigator title: Principal Investigator
mesh term: Barrett Esophagus
mesh term: Esophagitis
mesh term: Eosinophilic Esophagitis
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 