<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/NCT03830801</url>
  </required_header>
  <id_info>
    <org_study_id>2017-P001752</org_study_id>
    <secondary_id>5R01EB022077-02</secondary_id>
    <nct_id>NCT03830801</nct_id>
  </id_info>
  <brief_title>Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus</brief_title>
  <acronym>IVLCM</acronym>
  <official_title>Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus</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 for Biomedical Imaging and Bioengineering (NIBIB)</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>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators have developed a new technology, termed in-vivo laser capture&#xD;
      microdissection (IVLCM), that addresses the limitations of endoscopic biopsy for screening&#xD;
      for BE and provides targeted genomic profiling of aberrant tissue for more precise prediction&#xD;
      of EAC risk. The device is a tethered capsule endomicroscope (TCE) that implements optical&#xD;
      coherence tomography (OCT) to grab 10-mm-resolution, cross-sectional microscopic images of&#xD;
      the entire esophagus after the capsule is swallowed. This OCT-based TCE technology is used in&#xD;
      unsedated patients to visualize images of BE and dysplastic BE. During the IVLCM procedure,&#xD;
      TCE images of abnormal BE tissue are identified in real time and selectively adhered onto the&#xD;
      device. When the capsule is removed from the patient, these tissues, targeted based on their&#xD;
      abnormal OCT morphology, are sent for genomic analysis. By enabling the precise isolation of&#xD;
      aberrant esophageal tissues using a swallowable capsule, this technology has the potential to&#xD;
      solve the major problems that currently prohibit adequate BE screening and prevention of&#xD;
      Esophageal Adenocarcinoma EAC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Vivo Laser Capture Microdissection (IVLCM). The IVLCM tethered capsule is identical to&#xD;
      those used in current approved OCT TCE studies.The capsule is swallowed by the patient and&#xD;
      then, in real time, a region for tissue capture, is identified on the images. When a targeted&#xD;
      site is identified, a capture laser (1450 nm, 0.8 W, 1 second exposure; within the range of&#xD;
      the previously approved OCT-TCE tissue marking study) irradiates this area in the patient,&#xD;
      heating the water in the tissue and transforming it to steam. The accumulated water steam&#xD;
      overcomes the tissue matrix's adhesion force, ejecting a small amount of tissue and&#xD;
      integrating it with the capsule's external shell. This process may then be repeated to&#xD;
      collect multiple samples. After the device is pulled out from the patient, the captured&#xD;
      tissues can be extracted for genomic analysis. Ex vivo animal tissue studies have shown that&#xD;
      capture laser does not damage DNA/RNA; high quality whole genome information can be obtained.&#xD;
&#xD;
      In this IVLCM study, the investigators are using a 1450 nm laser to capture tissue that was&#xD;
      previously approved to make cautery &quot;marks&quot; in the esophagus. The IVLCM capture laser's&#xD;
      specifications are the same as those of the marking laser and the power will be within the&#xD;
      IRB approved power range (0.82 W 1s). Prior to testing laser marking in humans, the&#xD;
      investigators first demonstrated the safety of laser marking in animals in vivo. Histological&#xD;
      assessment showed that the cautery marks did not penetrate through the submucosa and the vast&#xD;
      majority of the effects were limited to the epithelium, lamina propria, and muscularis mucosa&#xD;
      layers. The extent of thermal damage was comparable to conventional biopsies in standard of&#xD;
      care endoscopic biopsy procedures. After this animal study, the investigators conducted a&#xD;
      pilot study in humans in which over 30 marks were made in 22 enrolled subjects without any&#xD;
      adverse events or safety concerns. In addition to these balloon studies, the investigators&#xD;
      are currently conducting a TCE marking study. So far, the investigators have imaged and&#xD;
      marked 13 subjects through a capsule without any adverse effects or safety concerns.&#xD;
&#xD;
      Thirty (N=30) subjects will be enrolled in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 6, 2017</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of subjects from which we will be able to collect biopsy samples using IVLCM technique</measure>
    <time_frame>5 months</time_frame>
    <description>We will measure the number of subjects from which we will be able to collect biopsy samples using IVLCM technique</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Barrett Esophagus</condition>
  <arm_group>
    <arm_group_label>IVLCM tethered capsule for biopsies</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IVLCM tethered capsule for obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IVLCM tethered capsule</intervention_name>
    <description>Obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk using IVLCM tethered capsule</description>
    <arm_group_label>IVLCM tethered capsule for biopsies</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing an EGD with biopsy.&#xD;
&#xD;
          -  Patients must be over the age of 18.&#xD;
&#xD;
          -  Patients must be able to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Patients who are on anti-platelet medications or anti-coagulation medications, and&#xD;
             NSAIDS at the time of procedure.&#xD;
&#xD;
          -  Patients with a history of hemostasis disorders.&#xD;
&#xD;
          -  Patients with esophageal strictures, resulting in a luminal diameter smaller than the&#xD;
             diameter of the capsule.&#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>Gary Tearney, MD., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anna Gao, RN</last_name>
    <phone>617-643-6092</phone>
    <email>Tearneylabtrials@partners.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anita Chung, RN</last_name>
    <phone>617-724-4515</phone>
    <email>Tearneylabtrials@partners.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Gao, RN</last_name>
      <phone>617-643-6092</phone>
      <email>Tearneylabtrials@partners.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</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>Barrett's Esophagus</keyword>
  <keyword>EGD</keyword>
  <keyword>Endoscopy</keyword>
  <keyword>Biopsy</keyword>
  <keyword>Tethered Capulse Endomicroscopy</keyword>
  <keyword>OCT</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>
  <!-- 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/NCT03830801
org study id: 2017-P001752
secondary id: 5R01EB022077-02
nct id: NCT03830801
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The investigators have developed a new technology, termed in-vivo laser capture
      microdissection (IVLCM), that addresses the limitations of endoscopic biopsy for screening
      for BE and provides targeted genomic profiling of aberrant tissue for more precise prediction
      of EAC risk. The device is a tethered capsule endomicroscope (TCE) that implements optical
      coherence tomography (OCT) to grab 10-mm-resolution, cross-sectional microscopic images of
      the entire esophagus after the capsule is swallowed. This OCT-based TCE technology is used in
      unsedated patients to visualize images of BE and dysplastic BE. During the IVLCM procedure,
      TCE images of abnormal BE tissue are identified in real time and selectively adhered onto the
      device. When the capsule is removed from the patient, these tissues, targeted based on their
      abnormal OCT morphology, are sent for genomic analysis. By enabling the precise isolation of
      aberrant esophageal tissues using a swallowable capsule, this technology has the potential to
      solve the major problems that currently prohibit adequate BE screening and prevention of
      Esophageal Adenocarcinoma EAC.
In Vivo Laser Capture Microdissection (IVLCM). The IVLCM tethered capsule is identical to
      those used in current approved OCT TCE studies.The capsule is swallowed by the patient and
      then, in real time, a region for tissue capture, is identified on the images. When a targeted
      site is identified, a capture laser (1450 nm, 0.8 W, 1 second exposure; within the range of
      the previously approved OCT-TCE tissue marking study) irradiates this area in the patient,
      heating the water in the tissue and transforming it to steam. The accumulated water steam
      overcomes the tissue matrix's adhesion force, ejecting a small amount of tissue and
      integrating it with the capsule's external shell. This process may then be repeated to
      collect multiple samples. After the device is pulled out from the patient, the captured
      tissues can be extracted for genomic analysis. Ex vivo animal tissue studies have shown that
      capture laser does not damage DNA/RNA; high quality whole genome information can be obtained.

      In this IVLCM study, the investigators are using a 1450 nm laser to capture tissue that was
      previously approved to make cautery "marks" in the esophagus. The IVLCM capture laser's
      specifications are the same as those of the marking laser and the power will be within the
      IRB approved power range (0.82 W 1s). Prior to testing laser marking in humans, the
      investigators first demonstrated the safety of laser marking in animals in vivo. Histological
      assessment showed that the cautery marks did not penetrate through the submucosa and the vast
      majority of the effects were limited to the epithelium, lamina propria, and muscularis mucosa
      layers. The extent of thermal damage was comparable to conventional biopsies in standard of
      care endoscopic biopsy procedures. After this animal study, the investigators conducted a
      pilot study in humans in which over 30 marks were made in 22 enrolled subjects without any
      adverse events or safety concerns. In addition to these balloon studies, the investigators
      are currently conducting a TCE marking study. So far, the investigators have imaged and
      marked 13 subjects through a capsule without any adverse effects or safety concerns.

      Thirty (N=30) subjects will be enrolled in this study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: The number of subjects from which we will be able to collect biopsy samples using IVLCM technique
time frame: 5 months
description: We will measure the number of subjects from which we will be able to collect biopsy samples using IVLCM technique
arm group label: IVLCM tethered capsule for biopsies
arm group type: Experimental
description: IVLCM tethered capsule for obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk.
intervention type: Device
intervention name: IVLCM tethered capsule
description: Obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk using IVLCM tethered capsule
arm group label: IVLCM tethered capsule for biopsies
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gary Tearney, MD., PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Anna Gao, RN
phone: 617-643-6092
email: Tearneylabtrials@partners.org
last name: Anita Chung, RN
phone: 617-724-4515
email: Tearneylabtrials@partners.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Guillermo Tearney
investigator title: Principal Investigator
mesh term: Barrett Esophagus
sharing ipd: No