<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/NCT02193581</url>
  </required_header>
  <id_info>
    <org_study_id>OMS 001_HMO</org_study_id>
    <nct_id>NCT02193581</nct_id>
  </id_info>
  <brief_title>Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging</brief_title>
  <official_title>Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging: the MDS (Melanoma Detecting System)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orlucent, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Orlucent, Inc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of MDS to access the presence of melanoma in the skin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to&#xD;
      provide a score that correlates with the probability for the presence of melanoma in the&#xD;
      lesion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The MDS produces a score between 1 to 10.</measure>
    <time_frame>28 days</time_frame>
    <description>The score is a composite of the images of the mole, plus demographic and clinical information. The score is ranked from 1 to 10, with 1 being the lowest risk for melanoma, and 10 being the highest risk.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Skin Lesion</condition>
  <arm_group>
    <arm_group_label>Suspicious skin lesions.</arm_group_label>
    <description>Patients with a suspicious skin lesion referred for a biopsy are tested using MDS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MDS</intervention_name>
    <description>Patients with a suspicious lesion, referred for a biopsy is tested using MDS.</description>
    <arm_group_label>Suspicious skin lesions.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individual referred by a dermatologist or plastic surgeon for a skin biopsy or lesion&#xD;
        excision.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals with skin lesion with one or more of the ABCDE features and recommended&#xD;
             for a skin biopsy.&#xD;
&#xD;
          -  The lesion is accessible to the imaging device, with at least 1 cm of skin around the&#xD;
             lesion that is accessible to the MDS.&#xD;
&#xD;
          -  Male and female ≥ 21 years old.&#xD;
&#xD;
          -  Subject is capable of giving written informed consent.&#xD;
&#xD;
          -  Primary excision.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The lesion is less than 1 cm from the eyes.&#xD;
&#xD;
          -  The lesion is on the palms of hands or soles of the feet.&#xD;
&#xD;
          -  Mucosal lesion.&#xD;
&#xD;
          -  Pregnant females.&#xD;
&#xD;
          -  Low study procedure compliance.&#xD;
&#xD;
          -  Patients who are mentally or physically unable to comply with all aspects of the&#xD;
             study.&#xD;
&#xD;
          -  Undergoing chemotherapy.&#xD;
&#xD;
          -  Minor or legally incompetent and not able to sign the consent form.&#xD;
&#xD;
          -  Patient previously tested by MDS and was diagnosed with melanoma during the study.&#xD;
&#xD;
          -  Sensitivity to fluorescein&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon Merims, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>February 14, 2018</last_update_submitted>
  <last_update_submitted_qc>February 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT02193581
org study id: OMS 001_HMO
nct id: NCT02193581
lead sponsor: 
collaborator: 
has dmc: Yes
The use of MDS to access the presence of melanoma in the skin.
A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to
      provide a score that correlates with the probability for the presence of melanoma in the
      lesion.
observational model: Case-Only
time perspective: Prospective
measure: The MDS produces a score between 1 to 10.
time frame: 28 days
description: The score is a composite of the images of the mole, plus demographic and clinical information. The score is ranked from 1 to 10, with 1 being the lowest risk for melanoma, and 10 being the highest risk.
arm group label: Suspicious skin lesions.
description: Patients with a suspicious skin lesion referred for a biopsy are tested using MDS
intervention type: Device
intervention name: MDS
description: Patients with a suspicious lesion, referred for a biopsy is tested using MDS.
arm group label: Suspicious skin lesions.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Sharon Merims, MD
role: Principal Investigator
affiliation: Hadassah Medical Organization
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Melanoma