<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/NCT02210039</url>
  </required_header>
  <id_info>
    <org_study_id>2013-P-001213</org_study_id>
    <nct_id>NCT02210039</nct_id>
  </id_info>
  <brief_title>Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe</brief_title>
  <official_title>Pilot Study to Image the Esophagus Using a SECM Probe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is being done to test the feasibility and tolerability of a SECM imaging probe in&#xD;
      patients with Barrett's Esophagus (BE).&#xD;
&#xD;
      Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM&#xD;
      imaging will be performed continuously over a pre-determined length. Patients will later be&#xD;
      asked for their feedback.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects with a previous diagnosis of Barrett's Esophagus will be recruited in the study and&#xD;
      undergo SECM probe imaging while using conscious sedation, pulse oximetry and blood pressure&#xD;
      monitoring. The probe will be inserted the predetermined required distance in the esophagus&#xD;
      using a guide wire.&#xD;
&#xD;
      Once the SECM imaging probe is in place, spiral SECM image data will be continuously&#xD;
      collected over a pre-determined length (approximately 5cm).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Tolerability of the Procedure</measure>
    <time_frame>During the procedure</time_frame>
    <description>We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Barrett's Esophagus</condition>
  <arm_group>
    <arm_group_label>SECM Probe Imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SECM Probe</intervention_name>
    <description>Imaging of the esophagus using SECM probe and system.</description>
    <arm_group_label>SECM Probe Imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A previous diagnosis of Barrett's Esophagus&#xD;
&#xD;
          -  Patients must be over the age of 18&#xD;
&#xD;
          -  Patient must be able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with any history of intestinal strictures&#xD;
&#xD;
          -  OR subjects with a history of prior GI surgery&#xD;
&#xD;
          -  OR subjects with a history of intestinal Crohn's disease.&#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>April 2019</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <results_first_submitted>July 18, 2018</results_first_submitted>
  <results_first_submitted_qc>September 26, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 23, 2018</results_first_posted>
  <last_update_submitted>April 1, 2019</last_update_submitted>
  <last_update_submitted_qc>April 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 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>SECM</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SECM Probe Imaging</title>
          <description>SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.&#xD;
SECM Probe: Imaging of the esophagus using SECM probe 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="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </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>SECM Probe Imaging</title>
          <description>SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.&#xD;
SECM Probe: Imaging of the esophagus using SECM probe and system.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </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="4"/>
                  </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="65.16" spread="12.20"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Tolerability of the Procedure</title>
        <description>We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.</description>
        <time_frame>During the procedure</time_frame>
        <population>All six study participants completed the study and the obtained data has been analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>SECM Probe Imaging</title>
            <description>SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.&#xD;
SECM Probe: Imaging of the esophagus using SECM probe and system.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Tolerability of the Procedure</title>
          <description>We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.</description>
          <population>All six study participants completed the study and the obtained data has been analyzed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the procedure</time_frame>
      <desc>The adverse events were collected systematically for this study. The definition of adverse events is the same as clinicaltrials.gov definition.</desc>
      <group_list>
        <group group_id="E1">
          <title>SECM Probe Imaging</title>
          <description>SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.&#xD;
SECM Probe: Imaging of the esophagus using SECM probe and system.&#xD;
No adverse events has been reported.</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="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
              </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="6"/>
              </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>Guillermo 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/NCT02210039
org study id: 2013-P-001213
nct id: NCT02210039
lead sponsor: 
has dmc: No
The study is being done to test the feasibility and tolerability of a SECM imaging probe in
      patients with Barrett's Esophagus (BE).

      Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM
      imaging will be performed continuously over a pre-determined length. Patients will later be
      asked for their feedback.
Subjects with a previous diagnosis of Barrett's Esophagus will be recruited in the study and
      undergo SECM probe imaging while using conscious sedation, pulse oximetry and blood pressure
      monitoring. The probe will be inserted the predetermined required distance in the esophagus
      using a guide wire.

      Once the SECM imaging probe is in place, spiral SECM image data will be continuously
      collected over a pre-determined length (approximately 5cm).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Number of Participants With Tolerability of the Procedure
time frame: During the procedure
description: We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.
arm group label: SECM Probe Imaging
arm group type: Experimental
description: SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.
intervention type: Device
intervention name: SECM Probe
description: Imaging of the esophagus using SECM probe and system.
arm group label: SECM Probe 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: Barrett Esophagus
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 