<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/NCT02202590</url>
  </required_header>
  <id_info>
    <org_study_id>2013-P000863</org_study_id>
    <secondary_id>5R01DK091923-03</secondary_id>
    <nct_id>NCT02202590</nct_id>
  </id_info>
  <brief_title>Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus</brief_title>
  <official_title>Pilot Study to Image the Esophagus Using Spectrally Encoded Confocal Microscopy (SECM)</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 Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to test the feasibility and the tolerability of a tethered&#xD;
      spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      72 subjects including healthy volunteers, patients with a suspicion of having Eosinophilic&#xD;
      Esophagitis (EoE) and patients with a clinical diagnosis of EoE will be recruited and asked&#xD;
      to swallow the SECM capsule while being awake and unsedated. The capsule is attached to a&#xD;
      tether which allows the operator to control as well as navigate the capsule as it progresses&#xD;
      down the esophagus using natural propulsive force called peristalsis.&#xD;
&#xD;
      As the capsule progresses, multiple 2-dimensional cross sectional images of the esophagus are&#xD;
      acquired. Images are analyzed at a later stage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 2013</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc.</measure>
    <time_frame>A single 20 minute visit (5-7 minute imaging).</time_frame>
    <description>An investigator will qualitatively assess the the Feasibility of SECM Capsule and Imaging in EoE participant versus Healthy Controls. He will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. The images obtained by the SECM Capsule will be compared to the images obtained by clinical endoscopy if available.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores.</measure>
    <time_frame>Questionnaire adminstered directly after the imaging portion has been completed.</time_frame>
    <description>After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire. This entails questions about discomfort levels and the participants ability to tolerate the tether and capsule during the whole and parts of the procedures. using a 0 -10 scale, participants will score how comfortable the procedure was during each stage. 10 being the most discomfort and 0 being the least discomfort.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Eosinophilic Esophagitis</condition>
  <arm_group>
    <arm_group_label>Imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SECM Capsule</intervention_name>
    <description>Imaging of the esophagus using the SECM capsule and system</description>
    <arm_group_label>Imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be a healthy volunteer&#xD;
&#xD;
          -  OR subject must have a suspicion of EoE&#xD;
&#xD;
          -  OR subject must have a prior clinical suspicion of EoE&#xD;
&#xD;
          -  Subject must be older than 14 years of age&#xD;
&#xD;
          -  Subject must be able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with the inability to swallow pills and capsules.&#xD;
&#xD;
          -  Esophageal fistula and/or esophageal strictures with a stricture diameter that is&#xD;
             smaller than the diameter of the capsule.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 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>January 2023</verification_date>
  <study_first_submitted>June 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</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</investigator_title>
  </responsible_party>
  <keyword>SECM</keyword>
  <keyword>Esophagus</keyword>
  <keyword>Eosinophilic Esophagitis</keyword>
  <keyword>Allergy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophagitis</mesh_term>
    <mesh_term>Eosinophilic Esophagitis</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/NCT02202590
org study id: 2013-P000863
secondary id: 5R01DK091923-03
nct id: NCT02202590
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The goal of this study is to test the feasibility and the tolerability of a tethered
      spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.
72 subjects including healthy volunteers, patients with a suspicion of having Eosinophilic
      Esophagitis (EoE) and patients with a clinical diagnosis of EoE will be recruited and asked
      to swallow the SECM capsule while being awake and unsedated. The capsule is attached to a
      tether which allows the operator to control as well as navigate the capsule as it progresses
      down the esophagus using natural propulsive force called peristalsis.

      As the capsule progresses, multiple 2-dimensional cross sectional images of the esophagus are
      acquired. Images are analyzed at a later stage.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc.
time frame: A single 20 minute visit (5-7 minute imaging).
description: An investigator will qualitatively assess the the Feasibility of SECM Capsule and Imaging in EoE participant versus Healthy Controls. He will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. The images obtained by the SECM Capsule will be compared to the images obtained by clinical endoscopy if available.
measure: Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores.
time frame: Questionnaire adminstered directly after the imaging portion has been completed.
description: After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire. This entails questions about discomfort levels and the participants ability to tolerate the tether and capsule during the whole and parts of the procedures. using a 0 -10 scale, participants will score how comfortable the procedure was during each stage. 10 being the most discomfort and 0 being the least discomfort.
arm group label: Imaging
arm group type: Experimental
description: Subject will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system.
intervention type: Device
intervention name: SECM Capsule
description: Imaging of the esophagus using the SECM capsule and system
arm group label: Imaging
criteria: 
gender: All
minimum age: 14 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: Esophagitis
mesh term: Eosinophilic Esophagitis
sharing ipd: No