<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/NCT02202681</url>
  </required_header>
  <id_info>
    <org_study_id>2013-P001405</org_study_id>
    <nct_id>NCT02202681</nct_id>
  </id_info>
  <brief_title>Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule</brief_title>
  <official_title>Pilot Study for Imaging of the Duodenum Using an OFDI Capsule</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule&#xD;
      to image the duodenum.&#xD;
&#xD;
      A total of 24 subjects will be asked to swallow the tethered capsule, while they are awake&#xD;
      and unsedated and ask for their feedback. Images will be taken using the OFDI system while&#xD;
      the capsule travels from the esophagus into the stomach and into the duodenum.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects including healthy volunteers as well as patients with Celiac disease will be&#xD;
      recruited and asked to swallow the OFDI capsule while being awake and unsedated. The capsule&#xD;
      is attached to a tether which allows the operator to control as well as navigate the capsule&#xD;
      as it progresses down the esophagus, through the stomach and into the duodenum using natural&#xD;
      propulsive force called peristalsis.&#xD;
&#xD;
      As the capsule progresses, multiple 2-dimensional cross sectional images of the duodenum are&#xD;
      acquired. Images are analyzed at a later stage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">September 16, 2013</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">October 28, 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>Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule</measure>
    <time_frame>Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours.</time_frame>
    <description>After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire.</description>
  </primary_outcome>
  <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 on average take anywhere from 30 minutes to 2 hours</time_frame>
    <description>An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Celiac Disease</condition>
  <condition>Healthy</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 performed using the OFDI system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OFDI Capsule</intervention_name>
    <description>Imaging of the duodenum with the OFDI capsule and system</description>
    <arm_group_label>OFDI Capsule Imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be over 18 years for healthy volunteers&#xD;
&#xD;
          -  Subjects must be over 16 years for patients with Celiac disease&#xD;
&#xD;
          -  Subject must be able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with an inability to swallow pills or capsules.&#xD;
&#xD;
          -  Subjects with esophageal or intestinal fistulas.&#xD;
&#xD;
          -  Subjects with known esophageal or intestinal strictures resulting in a luminal&#xD;
             diameter smaller than the diameter of the capsule.&#xD;
&#xD;
          -  Subjects with a history of intestinal Crohn's disease.&#xD;
&#xD;
          -  Women who are pregnant.&#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>January 2023</verification_date>
  <study_first_submitted>June 12, 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>Duodenum</keyword>
  <keyword>Optical Frequency Domain Imaging (OFDI)</keyword>
  <keyword>Optical Coherence Tomography</keyword>
  <keyword>Imaging</keyword>
  <keyword>Celiac Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celiac Disease</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/NCT02202681
org study id: 2013-P001405
nct id: NCT02202681
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule
      to image the duodenum.

      A total of 24 subjects will be asked to swallow the tethered capsule, while they are awake
      and unsedated and ask for their feedback. Images will be taken using the OFDI system while
      the capsule travels from the esophagus into the stomach and into the duodenum.
Subjects including healthy volunteers as well as patients with Celiac disease will be
      recruited and asked to swallow the OFDI 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, through the stomach and into the duodenum using natural
      propulsive force called peristalsis.

      As the capsule progresses, multiple 2-dimensional cross sectional images of the duodenum 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: Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule
time frame: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours.
description: After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire.
measure: Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule
time frame: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours
description: An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed.
arm group label: OFDI Capsule Imaging
arm group type: Experimental
description: Subject will swallow the OFDI Capsule and imaging will be performed using the OFDI system.
intervention type: Device
intervention name: OFDI Capsule
description: Imaging of the duodenum with 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: Celiac Disease
sharing ipd: No