<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/NCT02215291</url>
  </required_header>
  <id_info>
    <org_study_id>13_02</org_study_id>
    <nct_id>NCT02215291</nct_id>
  </id_info>
  <brief_title>NvisionVLE™ Registry System Registry</brief_title>
  <official_title>High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NinePoint Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NinePoint Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or&#xD;
      endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural&#xD;
      data for participating physicians, including, but not limited to, imaging data, clinical&#xD;
      utility data, demographics, pathology, treatment, and surveillance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-site registry with longitudinal follow up for patients&#xD;
      undergoing EGD or endoscopy. The primary objective is to provide a collection of patient&#xD;
      NvisionVLE™ procedural data for participating physicians, including, but not limited to,&#xD;
      imaging data, clinical utility data, demographics, pathology, treatment, and surveillance.&#xD;
&#xD;
      Up to 1000 patients from up to 20 sites nationwide.&#xD;
&#xD;
      There are no protocol defined follow up visits. Patients will undergo an initial baseline&#xD;
      Volumetric Laser Endomicroscopy (VLE) procedure. A patient with a negative screening&#xD;
      examination may not require additional screening endoscopies. For patients with established&#xD;
      disease, further surveillance endoscopies will vary based on the extent of the disease (e.g.&#xD;
      every 3 months, every 6 months, annual), which is based on the following American Society for&#xD;
      Gastrointestinal Endoscopy (ASGE) guideline: the role of endoscopy in the surveillance of&#xD;
      premalignant conditions of the upper GI tract. If patients have additional VLE procedures&#xD;
      during the enrollment period, associated data will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Percent of patients with endoscopically visible disease/ suspicious areas as determined by the physician</measure>
    <time_frame>Baseline</time_frame>
    <description>No protocol defined follow up visits. Patients will undergo an initial baseline Volumetric Laser Endomicroscopy (VLE) procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of patients with VLE visible abnormalities/ suspicious areas as determined by the physician</measure>
    <time_frame>Baseline</time_frame>
    <description>No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of patients with histologically confirmed disease and a breakdown of diseases observed</measure>
    <time_frame>Baseline</time_frame>
    <description>No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of treated patients with endoscopic and VLE identified areas of retained or persistent abnormalities at the first endoscopic evaluation after treatment</measure>
    <time_frame>Baseline</time_frame>
    <description>No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of treated patients undergoing surveillance with endoscopic and VLE areas of recurrent abnormality diagnosed by histology as disease</measure>
    <time_frame>Baseline</time_frame>
    <description>No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of patients with abnormalities/ suspicious areas identified by the physician as subsquamous visualized on VLE and not seen on endoscopy</measure>
    <time_frame>Baseline</time_frame>
    <description>No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Esophagogastroduodenoscopy</condition>
  <arm_group>
    <arm_group_label>Patients undergoing EGD or esophagoscopy</arm_group_label>
    <description>The cohort includes patients undergoing EGD or esophagoscopy for initial diagnosis or initial staging and mapping, surveillance of non-treated disease, and treatment (initial or ongoing) or post-treatment surveillance</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 20 sites; each site will have the opportunity to enroll up to 100 patients. There&#xD;
        will be up to 1000 patients enrolled in the registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting for an endoscopic examination of the esophagus&#xD;
&#xD;
          -  Ability to provide written, informed consent to participate in the Registry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients for whom use of the NvisionVLE device would be in conflict with the&#xD;
             Instructions for Use (IFU)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Smith, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univeristy of South Alabama</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36688</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Health System</name>
      <address>
        <city>Kenner</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Boston Health Care System</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore/ LIJ</name>
      <address>
        <city>Long Island City</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College/NewYork-Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia Univeristy</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Pennsylvania Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Dallas Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Vermont Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>March 27, 2018</last_update_submitted>
  <last_update_submitted_qc>March 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Undergoing Esophagogastroduodenoscopy (EGD) or endoscopy</keyword>
  <!-- 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/NCT02215291
org study id: 13_02
nct id: NCT02215291
lead sponsor: 
has dmc: No
Prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or
      endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural
      data for participating physicians, including, but not limited to, imaging data, clinical
      utility data, demographics, pathology, treatment, and surveillance.
This is a prospective, multi-site registry with longitudinal follow up for patients
      undergoing EGD or endoscopy. The primary objective is to provide a collection of patient
      NvisionVLE™ procedural data for participating physicians, including, but not limited to,
      imaging data, clinical utility data, demographics, pathology, treatment, and surveillance.

      Up to 1000 patients from up to 20 sites nationwide.

      There are no protocol defined follow up visits. Patients will undergo an initial baseline
      Volumetric Laser Endomicroscopy (VLE) procedure. A patient with a negative screening
      examination may not require additional screening endoscopies. For patients with established
      disease, further surveillance endoscopies will vary based on the extent of the disease (e.g.
      every 3 months, every 6 months, annual), which is based on the following American Society for
      Gastrointestinal Endoscopy (ASGE) guideline: the role of endoscopy in the surveillance of
      premalignant conditions of the upper GI tract. If patients have additional VLE procedures
      during the enrollment period, associated data will be collected.
observational model: Cohort
time perspective: Prospective
measure: Percent of patients with endoscopically visible disease/ suspicious areas as determined by the physician
time frame: Baseline
description: No protocol defined follow up visits. Patients will undergo an initial baseline Volumetric Laser Endomicroscopy (VLE) procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
measure: Percent of patients with VLE visible abnormalities/ suspicious areas as determined by the physician
time frame: Baseline
description: No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
measure: Percent of patients with histologically confirmed disease and a breakdown of diseases observed
time frame: Baseline
description: No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
measure: Percent of treated patients with endoscopic and VLE identified areas of retained or persistent abnormalities at the first endoscopic evaluation after treatment
time frame: Baseline
description: No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
measure: Percent of treated patients undergoing surveillance with endoscopic and VLE areas of recurrent abnormality diagnosed by histology as disease
time frame: Baseline
description: No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
measure: Percent of patients with abnormalities/ suspicious areas identified by the physician as subsquamous visualized on VLE and not seen on endoscopy
time frame: Baseline
description: No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.
arm group label: Patients undergoing EGD or esophagoscopy
description: The cohort includes patients undergoing EGD or esophagoscopy for initial diagnosis or initial staging and mapping, surveillance of non-treated disease, and treatment (initial or ongoing) or post-treatment surveillance
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Michael Smith, MD, MBA
role: Principal Investigator
affiliation: Temple University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor