<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/NCT02204566</url>
  </required_header>
  <id_info>
    <org_study_id>2012-P-001952</org_study_id>
    <secondary_id>5R01CA103769-08</secondary_id>
    <nct_id>NCT02204566</nct_id>
  </id_info>
  <brief_title>OFDI Capsule Imaging in Patients With Atrial Fibrillation Undergone Radio Frequency (RF) Ablation</brief_title>
  <official_title>Pilot Study of OFDI Capsule Imaging of the Esophagus of Patients With Atrial Fibrillation Following RF Ablation</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>
      12 patients with Atrial Fibrillation, a kind of irregular heart beat who have undergone Radio&#xD;
      frequency (RF) ablation will be asked to swallow the capsule.&#xD;
&#xD;
      As they swallow the capsule, images of the esophagus will be taken to see if the RF ablation&#xD;
      caused any form of damage to the esophagus considering it being so close to the heart.&#xD;
&#xD;
      After the capsule has been removed from the mouth, they will be asked about the tolerability&#xD;
      of the capsule.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 12 patients with a known diagnosis of Atrial Fibrillation who have previously&#xD;
      undergone Atrial RF ablation will be enrolled in the study. Patients will be asked to swallow&#xD;
      the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the&#xD;
      capsule operator to navigate the capsule as it progresses down the esophagus using natural&#xD;
      propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when&#xD;
      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>January 2013</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule</measure>
    <time_frame>After the completed imaging session</time_frame>
    <description>An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. A total of 6 subjects were enrolled in this study. 1 participant was not analyzed as they could not attempt to swallow the capsule.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Atrial Fibrillation</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;
          -  Subjects must be over 18 years of age&#xD;
&#xD;
          -  Subjects must be able to give informed consent.&#xD;
&#xD;
          -  Subjects must be referred to Massachusetts General Hospital (MGH) endoscopy for RF&#xD;
             Ablation treatment of their Atrial Fibrillation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with current esophageal strictures and dysphagia&#xD;
&#xD;
          -  OR subjects with a prior history of intestinal strictures, prior GI surgery or&#xD;
             intestinal Crohn's disease.&#xD;
&#xD;
          -  OR subjects with a known history of chronic aspiration.&#xD;
&#xD;
          -  OR women who are currently pregnant.&#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>
  <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>October 2019</verification_date>
  <study_first_submitted>June 17, 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>July 30, 2019</results_first_submitted>
  <results_first_submitted_qc>July 30, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 26, 2019</results_first_posted>
  <last_update_submitted>October 24, 2019</last_update_submitted>
  <last_update_submitted_qc>October 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 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>Professor of Pathology</investigator_title>
  </responsible_party>
  <keyword>OFDI</keyword>
  <keyword>RF Ablation</keyword>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Imaging</keyword>
  <keyword>Esophagus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <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="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </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="5"/>
          </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62" spread="7"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule</title>
        <description>An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. A total of 6 subjects were enrolled in this study. 1 participant was not analyzed as they could not attempt to swallow the capsule.</description>
        <time_frame>After the completed imaging session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Feasibility</title>
            <description>Number of Participants with Acceptable Quality of Images Who Swallow the OFDI Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule</title>
          <description>An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. A total of 6 subjects were enrolled in this study. 1 participant was not analyzed as they could not attempt to swallow the capsule.</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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </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="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </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="5"/>
              </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>Dr. Gary Tearney, PI</name_or_title>
      <organization>Massachusetts 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/NCT02204566
org study id: 2012-P-001952
secondary id: 5R01CA103769-08
nct id: NCT02204566
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
12 patients with Atrial Fibrillation, a kind of irregular heart beat who have undergone Radio
      frequency (RF) ablation will be asked to swallow the capsule.

      As they swallow the capsule, images of the esophagus will be taken to see if the RF ablation
      caused any form of damage to the esophagus considering it being so close to the heart.

      After the capsule has been removed from the mouth, they will be asked about the tolerability
      of the capsule.
A total of 12 patients with a known diagnosis of Atrial Fibrillation who have previously
      undergone Atrial RF ablation will be enrolled in the study. Patients 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: Device Feasibility
masking: None (Open Label)
measure: Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule
time frame: After the completed imaging session
description: An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. A total of 6 subjects were enrolled in this study. 1 participant was not analyzed as they could not attempt to swallow the capsule.
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: 18 Years
maximum age: N/A
healthy volunteers: No
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: Professor of Pathology
mesh term: Atrial Fibrillation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 