<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/NCT01700114</url>
  </required_header>
  <id_info>
    <org_study_id>Protocol 20111</org_study_id>
    <nct_id>NCT01700114</nct_id>
  </id_info>
  <brief_title>Post-Approval Study of MelaFind</brief_title>
  <official_title>Post-Approval Study of MelaFind</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MELA Sciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MELA Sciences, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to collect data to describe the real-world use and safety and&#xD;
      effectiveness of MelaFind® in a post-approval clinical setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study to test the hypothesis that, among eligible and evaluable&#xD;
      lesions with central histological reference standard status melanoma or high-grade lesion,&#xD;
      the relative sensitivity ρ comparing enrolling dermatologists after MelaFind use with&#xD;
      enrolling dermatologists if MelaFind were not available is greater than 110%. This represents&#xD;
      a clinically meaningful increase in sensitivity.&#xD;
&#xD;
      The secondary objectives of this study are to evaluate real-world use and safety and&#xD;
      effectiveness of MelaFind in a clinical setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    FDA withdrew requirement to complete study&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available</measure>
    <time_frame>6 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To describe characteristics of patients and lesions with MelaFind, the experience of using MelaFind, distribution of test results, and details on biopsied lesions.</measure>
    <time_frame>6 years</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">487</enrollment>
  <condition>Melanoma</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MelaFind</intervention_name>
    <description>The device is used when a dermatologist chooses to obtain additional information on atypical skin lesions for a decision to biopsy.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      pathology slides of biopsied tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients of any age, race, ethnicity, or gender, presenting with pigmented skin lesions&#xD;
        that that meet the Indications for Use and Lesion Inclusion and Exclusion Criteria,&#xD;
        including signing the Informed Consent Form, are eligible to participate in this study.&#xD;
        This single-arm study has one study group consisting of eligible lesions on eligible&#xD;
        patients.&#xD;
&#xD;
        Up to six clinical sites in the US will participate in this study, one in each of the six&#xD;
        states in which MelaFind is commercially available. Some of the sites will be located in&#xD;
        urban settings, and some will be located in a suburban or rural setting. At least 50% of&#xD;
        the sites will new, i.e., they did not participate in the MelaFind pivotal study. Some&#xD;
        sites will be academic centers and some private practices.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The lesion is pigmented (i.e., melanin, keratin, blood)&#xD;
&#xD;
          -  Clinical management of the lesion by the examining dermatologist is either biopsy of&#xD;
             the lesion in toto, or 3-month follow-up of the lesion&#xD;
&#xD;
          -  The diameter of the pigmented area is between 2 and 22 millimeters&#xD;
&#xD;
          -  The lesion is accessible to the MelaFind hand-held imaging device&#xD;
&#xD;
          -  The patient, or a legally authorized representative, has consented to participate in&#xD;
             the study and has signed the Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient has a known allergy to isopropyl alcohol&#xD;
&#xD;
          -  The lesion has been previously biopsied, excised, or traumatized&#xD;
&#xD;
          -  The skin is not intact (e.g., open sores, ulcers, bleeding)&#xD;
&#xD;
          -  The lesion is within 1 cm of the eye&#xD;
&#xD;
          -  The lesion is on mucosal surfaces (e.g., lips, genitals)&#xD;
&#xD;
          -  The lesion is on palmar hands&#xD;
&#xD;
          -  The lesion is on plantar feet&#xD;
&#xD;
          -  The lesion is on or under nails&#xD;
&#xD;
          -  The lesion is located on or in an area of visible scarring&#xD;
&#xD;
          -  The lesion contains foreign matter (e.g., tattoo, splinter, marker)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Armand Cognetta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dermatology Associates of Tallahassee</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Timothy Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The John's Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Meg Gerstenblith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Nossa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Dermatology Group, P.C</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arthur Sober, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joel Cohen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AboutSkin Dermatology and DermSurgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AboutSkin Dermatology and DermSurgery</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Associates of Tallahassee</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Dermatology Group, P.C.</name>
      <address>
        <city>Verona</city>
        <state>New Jersey</state>
        <zip>07044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>March 10, 2016</last_update_submitted>
  <last_update_submitted_qc>March 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pigmented Skin Lesions</keyword>
  <keyword>Dermatology</keyword>
  <keyword>Skin Cancer</keyword>
  <keyword>Melanoma</keyword>
  <keyword>MelaFind</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</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/NCT01700114
org study id: Protocol 20111
nct id: NCT01700114
lead sponsor: 
has dmc: No
The purpose of this study is to collect data to describe the real-world use and safety and
      effectiveness of MelaFind® in a post-approval clinical setting.
The primary objective of this study to test the hypothesis that, among eligible and evaluable
      lesions with central histological reference standard status melanoma or high-grade lesion,
      the relative sensitivity ρ comparing enrolling dermatologists after MelaFind use with
      enrolling dermatologists if MelaFind were not available is greater than 110%. This represents
      a clinically meaningful increase in sensitivity.

      The secondary objectives of this study are to evaluate real-world use and safety and
      effectiveness of MelaFind in a clinical setting.
observational model: Cohort
time perspective: Prospective
measure: Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available
time frame: 6 years
measure: To describe characteristics of patients and lesions with MelaFind, the experience of using MelaFind, distribution of test results, and details on biopsied lesions.
time frame: 6 years
intervention type: Device
intervention name: MelaFind
description: The device is used when a dermatologist chooses to obtain additional information on atypical skin lesions for a decision to biopsy.
pathology slides of biopsied tissue
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Armand Cognetta, MD
role: Principal Investigator
affiliation: Dermatology Associates of Tallahassee
last name: Timothy Wang, MD
role: Principal Investigator
affiliation: The John's Hopkins University
last name: Meg Gerstenblith, MD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
last name: Robert Nossa, MD
role: Principal Investigator
affiliation: The Dermatology Group, P.C
last name: Arthur Sober, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Joel Cohen, MD
role: Principal Investigator
affiliation: AboutSkin Dermatology and DermSurgery
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Melanoma
sharing ipd: No