<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/NCT03814824</url>
  </required_header>
  <id_info>
    <org_study_id>18-0963</org_study_id>
    <nct_id>NCT03814824</nct_id>
  </id_info>
  <brief_title>Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS)</brief_title>
  <official_title>Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS): a Multi-center Randomized Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NinePoint Medical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwell Health</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective randomized clinical trial examining how IRIS (Intelligent Real-time&#xD;
      Image Segmentation) affects biopsy patterns in VLE (Volumetric laser endomicroscopy).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will undergo a VLE exam with and without IRIS per the standard of care. All patients&#xD;
      regardless of the study participation in this study would receive VLE with and without IRIS&#xD;
      clinically. They will be randomized into VLE without IRIS first vs VLE with IRIS first. The&#xD;
      BUDDY Randomization System, provided for use by the Northwell Health Biostatistics Unit, will&#xD;
      be used for this. Randomization will be stratified based on prior diagnosis of dysplasia. The&#xD;
      order in which the patient is randomized to will be recorded on the case report form. There&#xD;
      will be concealed allocation as the study coordinator performing the randomization will not&#xD;
      know the order of the next allocation.&#xD;
&#xD;
      Both VLE and IRIS imaging are being performed as standard of care. However, randomization of&#xD;
      the order allows for comparison of the two. Regions of interest (ROI) will be recorded using&#xD;
      a full scan and recorded on the case report form. The time to identification of ROIs will&#xD;
      also be recorded. Each group will then cross over such that the VLE without IRIS group will&#xD;
      then have IRIS turned on. ROI will then be recorded for each group based on full scans. A&#xD;
      consensus ROI will be recorded based on the two exams. Only one ROI per centimeter will be&#xD;
      allowed to avoid overlapping of laser marks. In addition, VLE without IRIS and IRIS marks&#xD;
      within 75 frames of each other or 2 hours (on a clock face orientation) will be considered&#xD;
      the same target.&#xD;
&#xD;
      Laser marking will then be performed. A double laser mark will be applied to all IRIS ROIs. A&#xD;
      single laser mark will be applied to VLE ROIs. Targeted biopsies will be taken of all laser&#xD;
      marks and placed in separate biopsy jars. Biopsies will be taken in between the laser marks&#xD;
      for double laser marked areas. For single laser marks, biopsies will be taken on either side&#xD;
      of the laser mark. Resection of visible lesions will then occur per standard of care (if&#xD;
      present) followed by random biopsies of the segment. Random biopsies are pinch biopsies every&#xD;
      1 cm the length of the Barrett's in a 4 quadrant fashion per gastrointestinal society&#xD;
      guidelines. There are no additional research biopsies being performed outside this study. The&#xD;
      targeted biopsies are based on the VLE features that are suspicious for dysplasia and thus&#xD;
      standard of care. The other biopsies being performed here are random biopsies which are also&#xD;
      being performed for standard of care. Biopsied samples will be stored per standard of care&#xD;
      procedures per the pathology department. They will not be stored for future research&#xD;
      purposes.&#xD;
&#xD;
      Following each procedure, the physician will be asked a series of Likert Scale questions to&#xD;
      assess the utility of IRIS in that procedure, including how it impacts their confidence in&#xD;
      image interpretation, their ability to assimilate data more easily and quickly, and their&#xD;
      overall perception of the technology.&#xD;
&#xD;
      Although, the VLE with IRIS and VLE without IRIS are being performed as standard of care, all&#xD;
      adverse events will be recorded and reported to the IRB.&#xD;
&#xD;
      All data will be entered into a central encrypted REDCap database.&#xD;
&#xD;
      Expert pathologists who specialize in gastrointestinal pathology will read the histology. A&#xD;
      second gastrointestinal pathologist will confirm any histologic diagnosis of dysplasia. This&#xD;
      is the standard of care at Northwell Health and academic medical centers per gastrointestinal&#xD;
      society guidelines.&#xD;
&#xD;
      All procedures (upper endoscopy, volumetric laser endomicroscopy, and IRIS enhanced VLE) will&#xD;
      be performed as standard of care. The prospective data collection and initial randomization&#xD;
      will be the research component. All data collected will be de-identified before being&#xD;
      transferred into a database. This will be kept in a safe place that is only accessible to the&#xD;
      research team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time for Image Interpretation (Mean)</measure>
    <time_frame>Index procedure, up to 1 hour</time_frame>
    <description>The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time for Image Interpretation (Mean - Scaled)</measure>
    <time_frame>Index procedure, up to 1 hour</time_frame>
    <description>The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time for Image Interpretation (Median - Scaled)</measure>
    <time_frame>Index procedure, up to 1 hour</time_frame>
    <description>The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of Barrett's will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjects With Dysplasia on Biopsies</measure>
    <time_frame>Index procedure</time_frame>
    <description>Biopsy yield (in terms of dysplasia present versus not present) of subjects with IRIS biopsies (double laser mark) will be compared to subjects with VLE without IRIS biopsies (single laser mark) and subjects with random biopsies (taken every 1cm in a four quadrant fashion throughout the length of the Barrett's).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Barrett's Esophagus Without Dysplasia</condition>
  <condition>Barrett's Esophagus With Dysplasia</condition>
  <condition>Barrett's Esophagus With Low Grade Dysplasia</condition>
  <condition>Barrett's Esophagus With High Grade Dysplasia</condition>
  <condition>Barrett's Esophagus With Dysplasia, Unspecified</condition>
  <arm_group>
    <arm_group_label>VLE without IRIS, followed by VLE with IRIS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VLE with IRIS, followed by VLE without IRIS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>IRIS (Intelligent real-time image segmentation)</intervention_name>
    <description>IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.</description>
    <arm_group_label>VLE with IRIS, followed by VLE without IRIS</arm_group_label>
    <arm_group_label>VLE without IRIS, followed by VLE with IRIS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>VLE (Volumetric laser endomicroscopy)</intervention_name>
    <description>VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</description>
    <arm_group_label>VLE with IRIS, followed by VLE without IRIS</arm_group_label>
    <arm_group_label>VLE without IRIS, followed by VLE with IRIS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older at the time of informed consent&#xD;
&#xD;
          -  Barrett's esophagus greater than 2 cm in length&#xD;
&#xD;
          -  Undergoing a scheduled upper endoscopy with VLE exam for surveillance as standard of&#xD;
             care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years old at the time of informed consent&#xD;
&#xD;
          -  Unable to provide written informed consent&#xD;
&#xD;
          -  Esophageal stenosis/stricture preventing VLE&#xD;
&#xD;
          -  Esophagitis&#xD;
&#xD;
          -  Severe medical comorbidities preventing endoscopy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Uncontrolled coagulopathy&#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>Arvind Trindade, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Shaheen NJ, Falk GW, Iyer PG, Gerson LB; American College of Gastroenterology. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus. Am J Gastroenterol. 2016 Jan;111(1):30-50; quiz 51. doi: 10.1038/ajg.2015.322. Epub 2015 Nov 3. Erratum In: Am J Gastroenterol. 2016 Jul;111(7):1077.</citation>
    <PMID>26526079</PMID>
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    <citation>Corley DA, Mehtani K, Quesenberry C, Zhao W, de Boer J, Weiss NS. Impact of endoscopic surveillance on mortality from Barrett's esophagus-associated esophageal adenocarcinomas. Gastroenterology. 2013 Aug;145(2):312-9.e1. doi: 10.1053/j.gastro.2013.05.004. Epub 2013 May 11.</citation>
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    <citation>Jankowski M, Wani S. Diagnostic and Management Implications of Basic Science Advances in Barrett's Esophagus. Curr Treat Options Gastroenterol. 2015 Mar;13(1):16-29. doi: 10.1007/s11938-014-0040-9.</citation>
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    <citation>Wolfsen HC, Sharma P, Wallace MB, Leggett C, Tearney G, Wang KK. Safety and feasibility of volumetric laser endomicroscopy in patients with Barrett's esophagus (with videos). Gastrointest Endosc. 2015 Oct;82(4):631-40. doi: 10.1016/j.gie.2015.03.1968. Epub 2015 May 6.</citation>
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    <PMID>28402993</PMID>
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    <PMID>28161451</PMID>
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    <citation>Swager AF, Tearney GJ, Leggett CL, van Oijen MGH, Meijer SL, Weusten BL, Curvers WL, Bergman JJGHM. Identification of volumetric laser endomicroscopy features predictive for early neoplasia in Barrett's esophagus using high-quality histological correlation. Gastrointest Endosc. 2017 May;85(5):918-926.e7. doi: 10.1016/j.gie.2016.09.012. Epub 2016 Sep 19.</citation>
    <PMID>27658906</PMID>
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  <reference>
    <citation>Leggett CL, Gorospe EC, Chan DK, Muppa P, Owens V, Smyrk TC, Anderson M, Lutzke LS, Tearney G, Wang KK. Comparative diagnostic performance of volumetric laser endomicroscopy and confocal laser endomicroscopy in the detection of dysplasia associated with Barrett's esophagus. Gastrointest Endosc. 2016 May;83(5):880-888.e2. doi: 10.1016/j.gie.2015.08.050. Epub 2015 Sep 3.</citation>
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  <reference>
    <citation>Trindade AJ, Vamadevan AS, Sejpal DV. Finding a needle in a haystack: use of volumetric laser endomicroscopy in targeting focal dysplasia in long-segment Barrett's esophagus. Gastrointest Endosc. 2015 Oct;82(4):756; discussion 757. doi: 10.1016/j.gie.2015.03.1984. Epub 2015 May 21. No abstract available.</citation>
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    <citation>Trindade AJ, George BJ, Berkowitz J, Sejpal DV, McKinley MJ. Volumetric laser endomicroscopy can target neoplasia not detected by conventional endoscopic measures in long segment Barrett's esophagus. Endosc Int Open. 2016 Mar;4(3):E318-22. doi: 10.1055/s-0042-101409.</citation>
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    <citation>Leggett CL, Gorospe E, Owens VL, Anderson M, Lutzke L, Wang KK. Volumetric laser endomicroscopy detects subsquamous Barrett's adenocarcinoma. Am J Gastroenterol. 2014 Feb;109(2):298-9. doi: 10.1038/ajg.2013.422. No abstract available.</citation>
    <PMID>24496431</PMID>
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    <citation>Swager AF, Boerwinkel DF, de Bruin DM, Faber DJ, van Leeuwen TG, Weusten BL, Meijer SL, Bergman JJ, Curvers WL. Detection of buried Barrett's glands after radiofrequency ablation with volumetric laser endomicroscopy. Gastrointest Endosc. 2016 Jan;83(1):80-8. doi: 10.1016/j.gie.2015.05.028. Epub 2015 Jun 26.</citation>
    <PMID>26124075</PMID>
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    <PMID>27694877</PMID>
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  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <results_first_submitted>February 9, 2022</results_first_submitted>
  <results_first_submitted_qc>September 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 7, 2022</results_first_posted>
  <last_update_submitted>September 12, 2022</last_update_submitted>
  <last_update_submitted_qc>September 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>VLE</keyword>
  <keyword>Volumetric laser endomicroscopy</keyword>
  <keyword>IRIS</keyword>
  <keyword>Intelligent real-time image segmentation</keyword>
  <keyword>Barrett's Esophagus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Barrett Esophagus</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03814824/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>133 of 148 subjects were randomized during their EGD procedure. Of those not randomized, 8 subjects had a segment of Barrett's esophagus less than 2cm, 3 subjects had esophagitis (LA Grade B or higher), and 4 subjects did not have a complete VLE exam due to technical malfunctions with the device.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>VLE Without IRIS, Followed by VLE With IRIS</title>
          <description>VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.&#xD;
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</description>
        </group>
        <group group_id="P2">
          <title>VLE With IRIS, Followed by VLE Without IRIS</title>
          <description>VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.&#xD;
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>VLE Without IRIS, Followed by VLE With IRIS</title>
          <description>VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.&#xD;
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</description>
        </group>
        <group group_id="B2">
          <title>VLE With IRIS, Followed by VLE Without IRIS</title>
          <description>VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.&#xD;
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="67"/>
            <count group_id="B2" value="66"/>
            <count group_id="B3" value="133"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="67"/>
                    <count group_id="B2" value="66"/>
                    <count group_id="B3" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="73"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="67"/>
                    <count group_id="B2" value="66"/>
                    <count group_id="B3" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time for Image Interpretation (Mean)</title>
        <description>The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.</description>
        <time_frame>Index procedure, up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLE Without IRIS, Followed by VLE With IRIS</title>
            <description>VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.&#xD;
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</description>
          </group>
          <group group_id="O2">
            <title>VLE With IRIS, Followed by VLE Without IRIS</title>
            <description>VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.&#xD;
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</description>
          </group>
        </group_list>
        <measure>
          <title>Time for Image Interpretation (Mean)</title>
          <description>The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.</description>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total interpretation time (VLE/IRIS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="3.75"/>
                    <measurement group_id="O2" value="4.6" spread="3.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interpretation time (VLE alone)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="2.08"/>
                    <measurement group_id="O2" value="2.4" spread="2.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>First Interpretation Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="2.08"/>
                    <measurement group_id="O2" value="4.6" spread="3.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second Interpretation Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="3.75"/>
                    <measurement group_id="O2" value="2.4" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time for Image Interpretation (Mean - Scaled)</title>
        <description>The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.</description>
        <time_frame>Index procedure, up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLE Without IRIS, Followed by VLE With IRIS</title>
            <description>VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.&#xD;
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</description>
          </group>
          <group group_id="O2">
            <title>VLE With IRIS, Followed by VLE Without IRIS</title>
            <description>VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.&#xD;
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</description>
          </group>
        </group_list>
        <measure>
          <title>Time for Image Interpretation (Mean - Scaled)</title>
          <description>The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.</description>
          <units>Centimeters/Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Scaled First Interpretation Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.86"/>
                    <measurement group_id="O2" value="1.1" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Scaled Second Interpretation Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.25"/>
                    <measurement group_id="O2" value="0.6" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time for Image Interpretation (Median - Scaled)</title>
        <description>The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of Barrett's will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.</description>
        <time_frame>Index procedure, up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLE Without IRIS, Followed by VLE With IRIS</title>
            <description>VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.&#xD;
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</description>
          </group>
          <group group_id="O2">
            <title>VLE With IRIS, Followed by VLE Without IRIS</title>
            <description>VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.&#xD;
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</description>
          </group>
        </group_list>
        <measure>
          <title>Time for Image Interpretation (Median - Scaled)</title>
          <description>The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of Barrett's will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.</description>
          <units>Centimeters/Minutes</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Scaled First Interpretation Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.86"/>
                    <measurement group_id="O2" value="1.0" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Scaled Second Interpretation Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="1.25"/>
                    <measurement group_id="O2" value="0.5" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjects With Dysplasia on Biopsies</title>
        <description>Biopsy yield (in terms of dysplasia present versus not present) of subjects with IRIS biopsies (double laser mark) will be compared to subjects with VLE without IRIS biopsies (single laser mark) and subjects with random biopsies (taken every 1cm in a four quadrant fashion throughout the length of the Barrett's).</description>
        <time_frame>Index procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLE Without IRIS</title>
            <description>VLE (Volumetric laser endomicroscopy) performed alone,&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</description>
          </group>
          <group group_id="O2">
            <title>VLE With IRIS</title>
            <description>VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging.&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.&#xD;
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.</description>
          </group>
          <group group_id="O3">
            <title>Seattle Protocol</title>
            <description>Standardized method of biopsy collection entailing taking biopsies every 1cm of the Barrett's segment in a 4 quadrant fashion, the current standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjects With Dysplasia on Biopsies</title>
          <description>Biopsy yield (in terms of dysplasia present versus not present) of subjects with IRIS biopsies (double laser mark) will be compared to subjects with VLE without IRIS biopsies (single laser mark) and subjects with random biopsies (taken every 1cm in a four quadrant fashion throughout the length of the Barrett's).</description>
          <units>Participants with dysplasia on biopsies</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="133"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 week</time_frame>
      <group_list>
        <group group_id="E1">
          <title>VLE Without IRIS</title>
          <description>VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.&#xD;
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</description>
        </group>
        <group group_id="E2">
          <title>VLE With IRIS</title>
          <description>VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.&#xD;
IRIS (Intelligent real-time image segmentation): IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.&#xD;
VLE (Volumetric laser endomicroscopy): VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.</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="133"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="133"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="133"/>
              </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="133"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="133"/>
              </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>
    <limitations_and_caveats>By utilizing expert users, we're unable to assess the impact of IRIS on novice interpretation. We also utilized a surveillance biopsy protocol that avoided areas of laser marking to avoid confounding and were thus unable to compare VLE-related dysplasia detection to that which would have occurred in the standardized biopsy protocol. Finally, although we did randomize the order of interpretation, it is not possible to eliminate all bias from a subjective interpretation paradigm.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Arvind Trindade</name_or_title>
      <organization>Northwell Health</organization>
      <phone>516-387-3990</phone>
      <email>atrindade@northwell.edu</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/NCT03814824
org study id: 18-0963
nct id: NCT03814824
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a prospective randomized clinical trial examining how IRIS (Intelligent Real-time
      Image Segmentation) affects biopsy patterns in VLE (Volumetric laser endomicroscopy).
Patients will undergo a VLE exam with and without IRIS per the standard of care. All patients
      regardless of the study participation in this study would receive VLE with and without IRIS
      clinically. They will be randomized into VLE without IRIS first vs VLE with IRIS first. The
      BUDDY Randomization System, provided for use by the Northwell Health Biostatistics Unit, will
      be used for this. Randomization will be stratified based on prior diagnosis of dysplasia. The
      order in which the patient is randomized to will be recorded on the case report form. There
      will be concealed allocation as the study coordinator performing the randomization will not
      know the order of the next allocation.

      Both VLE and IRIS imaging are being performed as standard of care. However, randomization of
      the order allows for comparison of the two. Regions of interest (ROI) will be recorded using
      a full scan and recorded on the case report form. The time to identification of ROIs will
      also be recorded. Each group will then cross over such that the VLE without IRIS group will
      then have IRIS turned on. ROI will then be recorded for each group based on full scans. A
      consensus ROI will be recorded based on the two exams. Only one ROI per centimeter will be
      allowed to avoid overlapping of laser marks. In addition, VLE without IRIS and IRIS marks
      within 75 frames of each other or 2 hours (on a clock face orientation) will be considered
      the same target.

      Laser marking will then be performed. A double laser mark will be applied to all IRIS ROIs. A
      single laser mark will be applied to VLE ROIs. Targeted biopsies will be taken of all laser
      marks and placed in separate biopsy jars. Biopsies will be taken in between the laser marks
      for double laser marked areas. For single laser marks, biopsies will be taken on either side
      of the laser mark. Resection of visible lesions will then occur per standard of care (if
      present) followed by random biopsies of the segment. Random biopsies are pinch biopsies every
      1 cm the length of the Barrett's in a 4 quadrant fashion per gastrointestinal society
      guidelines. There are no additional research biopsies being performed outside this study. The
      targeted biopsies are based on the VLE features that are suspicious for dysplasia and thus
      standard of care. The other biopsies being performed here are random biopsies which are also
      being performed for standard of care. Biopsied samples will be stored per standard of care
      procedures per the pathology department. They will not be stored for future research
      purposes.

      Following each procedure, the physician will be asked a series of Likert Scale questions to
      assess the utility of IRIS in that procedure, including how it impacts their confidence in
      image interpretation, their ability to assimilate data more easily and quickly, and their
      overall perception of the technology.

      Although, the VLE with IRIS and VLE without IRIS are being performed as standard of care, all
      adverse events will be recorded and reported to the IRB.

      All data will be entered into a central encrypted REDCap database.

      Expert pathologists who specialize in gastrointestinal pathology will read the histology. A
      second gastrointestinal pathologist will confirm any histologic diagnosis of dysplasia. This
      is the standard of care at Northwell Health and academic medical centers per gastrointestinal
      society guidelines.

      All procedures (upper endoscopy, volumetric laser endomicroscopy, and IRIS enhanced VLE) will
      be performed as standard of care. The prospective data collection and initial randomization
      will be the research component. All data collected will be de-identified before being
      transferred into a database. This will be kept in a safe place that is only accessible to the
      research team.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Time for Image Interpretation (Mean)
time frame: Index procedure, up to 1 hour
description: The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.
measure: Time for Image Interpretation (Mean - Scaled)
time frame: Index procedure, up to 1 hour
description: The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of the Barrett's segment will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.
measure: Time for Image Interpretation (Median - Scaled)
time frame: Index procedure, up to 1 hour
description: The length of time required to fully assess and interpret the results of a VLE scan. Time will be a surrogate for ease of interpretation. Time will be recorded from start of image interpretation to the end of image interpretation. Length of Barrett's will be taken into account (time per cm of Barrett's) when comparing this outcome between patients and procedures.
measure: Subjects With Dysplasia on Biopsies
time frame: Index procedure
description: Biopsy yield (in terms of dysplasia present versus not present) of subjects with IRIS biopsies (double laser mark) will be compared to subjects with VLE without IRIS biopsies (single laser mark) and subjects with random biopsies (taken every 1cm in a four quadrant fashion throughout the length of the Barrett's).
arm group label: VLE without IRIS, followed by VLE with IRIS
arm group type: Active Comparator
description: VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.
arm group label: VLE with IRIS, followed by VLE without IRIS
arm group type: Active Comparator
description: VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.
intervention type: Diagnostic Test
intervention name: IRIS (Intelligent real-time image segmentation)
description: IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
arm group label: VLE with IRIS, followed by VLE without IRIS
arm group label: VLE without IRIS, followed by VLE with IRIS
intervention type: Diagnostic Test
intervention name: VLE (Volumetric laser endomicroscopy)
description: VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
arm group label: VLE with IRIS, followed by VLE without IRIS
arm group label: VLE without IRIS, followed by VLE with IRIS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arvind Trindade, MD
role: Principal Investigator
affiliation: Northwell Health
facility: 
facility: 
facility: 
country: United States
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PMID: 26526079
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PMID: 24700439
citation: Corley DA, Mehtani K, Quesenberry C, Zhao W, de Boer J, Weiss NS. Impact of endoscopic surveillance on mortality from Barrett's esophagus-associated esophageal adenocarcinomas. Gastroenterology. 2013 Aug;145(2):312-9.e1. doi: 10.1053/j.gastro.2013.05.004. Epub 2013 May 11.
PMID: 23673354
citation: Levine DS, Haggitt RC, Blount PL, Rabinovitch PS, Rusch VW, Reid BJ. An endoscopic biopsy protocol can differentiate high-grade dysplasia from early adenocarcinoma in Barrett's esophagus. Gastroenterology. 1993 Jul;105(1):40-50. doi: 10.1016/0016-5085(93)90008-z.
PMID: 8514061
citation: Jankowski M, Wani S. Diagnostic and Management Implications of Basic Science Advances in Barrett's Esophagus. Curr Treat Options Gastroenterol. 2015 Mar;13(1):16-29. doi: 10.1007/s11938-014-0040-9.
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citation: Trindade AJ, Smith MS, Pleskow DK. The new kid on the block for advanced imaging in Barrett's esophagus: a review of volumetric laser endomicroscopy. Therap Adv Gastroenterol. 2016 May;9(3):408-16. doi: 10.1177/1756283X16639003. Epub 2016 Mar 21.
PMID: 27134668
citation: Wolfsen HC, Sharma P, Wallace MB, Leggett C, Tearney G, Wang KK. Safety and feasibility of volumetric laser endomicroscopy in patients with Barrett's esophagus (with videos). Gastrointest Endosc. 2015 Oct;82(4):631-40. doi: 10.1016/j.gie.2015.03.1968. Epub 2015 May 6.
PMID: 25956472
citation: Trindade AJ, Leggett CL, Chang KJ. Volumetric laser endomicroscopy in the management of Barrett's esophagus. Curr Opin Gastroenterol. 2017 Jul;33(4):254-260. doi: 10.1097/MOG.0000000000000366.
PMID: 28402993
citation: Swager AF, de Groof AJ, Meijer SL, Weusten BL, Curvers WL, Bergman JJ. Feasibility of laser marking in Barrett's esophagus with volumetric laser endomicroscopy: first-in-man pilot study. Gastrointest Endosc. 2017 Sep;86(3):464-472. doi: 10.1016/j.gie.2017.01.030. Epub 2017 Feb 2.
PMID: 28161451
citation: Swager AF, Tearney GJ, Leggett CL, van Oijen MGH, Meijer SL, Weusten BL, Curvers WL, Bergman JJGHM. Identification of volumetric laser endomicroscopy features predictive for early neoplasia in Barrett's esophagus using high-quality histological correlation. Gastrointest Endosc. 2017 May;85(5):918-926.e7. doi: 10.1016/j.gie.2016.09.012. Epub 2016 Sep 19.
PMID: 27658906
citation: Leggett CL, Gorospe EC, Chan DK, Muppa P, Owens V, Smyrk TC, Anderson M, Lutzke LS, Tearney G, Wang KK. Comparative diagnostic performance of volumetric laser endomicroscopy and confocal laser endomicroscopy in the detection of dysplasia associated with Barrett's esophagus. Gastrointest Endosc. 2016 May;83(5):880-888.e2. doi: 10.1016/j.gie.2015.08.050. Epub 2015 Sep 3.
PMID: 26344884
citation: Trindade AJ, Vamadevan AS, Sejpal DV. Finding a needle in a haystack: use of volumetric laser endomicroscopy in targeting focal dysplasia in long-segment Barrett's esophagus. Gastrointest Endosc. 2015 Oct;82(4):756; discussion 757. doi: 10.1016/j.gie.2015.03.1984. Epub 2015 May 21. No abstract available.
PMID: 26005011
citation: Trindade AJ, George BJ, Berkowitz J, Sejpal DV, McKinley MJ. Volumetric laser endomicroscopy can target neoplasia not detected by conventional endoscopic measures in long segment Barrett's esophagus. Endosc Int Open. 2016 Mar;4(3):E318-22. doi: 10.1055/s-0042-101409.
PMID: 27004250
citation: Leggett CL, Gorospe E, Owens VL, Anderson M, Lutzke L, Wang KK. Volumetric laser endomicroscopy detects subsquamous Barrett's adenocarcinoma. Am J Gastroenterol. 2014 Feb;109(2):298-9. doi: 10.1038/ajg.2013.422. No abstract available.
PMID: 24496431
citation: Swager AF, Boerwinkel DF, de Bruin DM, Faber DJ, van Leeuwen TG, Weusten BL, Meijer SL, Bergman JJ, Curvers WL. Detection of buried Barrett's glands after radiofrequency ablation with volumetric laser endomicroscopy. Gastrointest Endosc. 2016 Jan;83(1):80-8. doi: 10.1016/j.gie.2015.05.028. Epub 2015 Jun 26.
PMID: 26124075
citation: Trindade AJ, Sideridis K, Thomas RM. Buried Barrett's Esophagus Presenting as a Subepithelial Nodule. Am J Gastroenterol. 2016 Oct;111(10):1378. doi: 10.1038/ajg.2016.242. No abstract available.
PMID: 27694877
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citation: Alshelleh M, Inamdar S, McKinley M, Stewart M, Novak JS, Greenberg RE, Sultan K, Devito B, Cheung M, Cerulli MA, Miller LS, Sejpal DV, Vegesna AK, Trindade AJ. Incremental yield of dysplasia detection in Barrett's esophagus using volumetric laser endomicroscopy with and without laser marking compared with a standardized random biopsy protocol. Gastrointest Endosc. 2018 Jul;88(1):35-42. doi: 10.1016/j.gie.2018.01.032. Epub 2018 Feb 2.
PMID: 29410080
citation: Trindade AJ, Inamdar S, Smith MS, Chang KJ, Leggett CL, Lightdale CJ, Pleskow DK, Sejpal DV, Tearney GJ, Thomas RM, Wallace MB. Volumetric laser endomicroscopy in Barrett's esophagus: interobserver agreement for interpretation of Barrett's esophagus and associated neoplasia among high-frequency users. Gastrointest Endosc. 2017 Jul;86(1):133-139. doi: 10.1016/j.gie.2016.11.026. Epub 2016 Nov 27.
PMID: 27899321
citation: Trindade AJ, Inamdar S, Smith MS, Rosen L, Han D, Chang KJ, Leggett CL, Lightdale CJ, Pleskow DK, Sejpal DV, Tearney GJ, Thomas RM, Wallace MB. Learning curve and competence for volumetric laser endomicroscopy in Barrett's esophagus using cumulative sum analysis. Endoscopy. 2018 May;50(5):471-478. doi: 10.1055/s-0043-121569. Epub 2017 Nov 27. Erratum In: Endoscopy. 2018 May;50(5):C10.
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citation: Evans JA, Poneros JM, Bouma BE, Bressner J, Halpern EF, Shishkov M, Lauwers GY, Mino-Kenudson M, Nishioka NS, Tearney GJ. Optical coherence tomography to identify intramucosal carcinoma and high-grade dysplasia in Barrett's esophagus. Clin Gastroenterol Hepatol. 2006 Jan;4(1):38-43. doi: 10.1053/S1542-3565(05)00746-9.
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citation: Swager AF, van der Sommen F, Klomp SR, Zinger S, Meijer SL, Schoon EJ, Bergman JJGHM, de With PH, Curvers WL. Computer-aided detection of early Barrett's neoplasia using volumetric laser endomicroscopy. Gastrointest Endosc. 2017 Nov;86(5):839-846. doi: 10.1016/j.gie.2017.03.011. Epub 2017 Mar 16.
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citation: Alvarez Herrero L, Curvers WL, van Vilsteren FG, Wolfsen H, Ragunath K, Wong Kee Song LM, Mallant-Hent RC, van Oijen A, Scholten P, Schoon EJ, Schenk EB, Weusten BL, Bergman JG. Validation of the Prague C&M classification of Barrett's esophagus in clinical practice. Endoscopy. 2013 Nov;45(11):876-82. doi: 10.1055/s-0033-1344952. Epub 2013 Oct 28.
PMID: 24165812
citation: The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon: November 30 to December 1, 2002. Gastrointest Endosc. 2003 Dec;58(6 Suppl):S3-43. doi: 10.1016/s0016-5107(03)02159-x. No abstract available.
PMID: 14652541
responsible party type: Sponsor
mesh term: Barrett Esophagus
mesh term: Hyperplasia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: By utilizing expert users, we're unable to assess the impact of IRIS on novice interpretation. We also utilized a surveillance biopsy protocol that avoided areas of laser marking to avoid confounding and were thus unable to compare VLE-related dysplasia detection to that which would have occurred in the standardized biopsy protocol. Finally, although we did randomize the order of interpretation, it is not possible to eliminate all bias from a subjective interpretation paradigm.
point of contact: 