<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/NCT03004053</url>
  </required_header>
  <id_info>
    <org_study_id>16-1652</org_study_id>
    <nct_id>NCT03004053</nct_id>
  </id_info>
  <brief_title>Feasibility Testing of a Novel Endoscope for Reflectance Confocal Microscopy of Normal Oral Tissue In Vivo</brief_title>
  <official_title>Feasibility Testing of a Novel Endoscope for Reflectance Confocal Microscopy of Normal Oral Tissue In Vivo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to obtain images (pictures) of normal oral tissue, which occur&#xD;
      inside the mouth, using a special camera. These pictures will be used in our research to&#xD;
      evaluate a new technology that uses a laser and takes pictures of the microscopic structure&#xD;
      of tissue. The technology is called &quot;reflectance confocal microscopy.&quot;&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">February 28, 2022</completion_date>
  <primary_completion_date type="Actual">February 28, 2022</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>number of images with acceptable quality</measure>
    <time_frame>1 year</time_frame>
    <description>Each image will be scored either 1 (completely unacceptable), 2 (unacceptable), 3 (possibly acceptable), 4 (acceptable) or 5 (very acceptable) relative to a reference standard The reference standard for appearance of adequate sectioning, resolution and contrast and for detectability of nuclear and cellular features will be the appearance of images and image quality, which we are intimately familiar with, based on the past several years of experience with the existing RCM device for which images of oral mucosa have been well-characterized, well-correlated to histology, and thus are well-understood.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Oral Tissue</condition>
  <arm_group>
    <arm_group_label>Volunteers will be identified by the Head and Neck Service</arm_group_label>
    <description>25 volunteers (Part I - 8 volunteers. Part II - 17 volunteers). during the course of 12 months. The volunteers will be imaged with the endoscope, and the images will be evaluated visually and with qualitative (descriptive) statistics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Reflectance Confocal Microscopy (RCM) endoscope device</intervention_name>
    <arm_group_label>Volunteers will be identified by the Head and Neck Service</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Head and Neck clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers&#xD;
&#xD;
          -  Ability to sign informed consent&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent.&#xD;
&#xD;
          -  Previously known oral disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Snehal Patel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Reflectance Confocal Microscopy</keyword>
  <keyword>Normal Oral Tissue</keyword>
  <keyword>16-1652</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/NCT03004053
org study id: 16-1652
nct id: NCT03004053
lead sponsor: 
The purpose of this study is to obtain images (pictures) of normal oral tissue, which occur
      inside the mouth, using a special camera. These pictures will be used in our research to
      evaluate a new technology that uses a laser and takes pictures of the microscopic structure
      of tissue. The technology is called "reflectance confocal microscopy."
observational model: Cohort
time perspective: Prospective
measure: number of images with acceptable quality
time frame: 1 year
description: Each image will be scored either 1 (completely unacceptable), 2 (unacceptable), 3 (possibly acceptable), 4 (acceptable) or 5 (very acceptable) relative to a reference standard The reference standard for appearance of adequate sectioning, resolution and contrast and for detectability of nuclear and cellular features will be the appearance of images and image quality, which we are intimately familiar with, based on the past several years of experience with the existing RCM device for which images of oral mucosa have been well-characterized, well-correlated to histology, and thus are well-understood.
arm group label: Volunteers will be identified by the Head and Neck Service
description: 25 volunteers (Part I - 8 volunteers. Part II - 17 volunteers). during the course of 12 months. The volunteers will be imaged with the endoscope, and the images will be evaluated visually and with qualitative (descriptive) statistics.
intervention type: Device
intervention name: Reflectance Confocal Microscopy (RCM) endoscope device
arm group label: Volunteers will be identified by the Head and Neck Service
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Snehal Patel, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor