<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/NCT03754426</url>
  </required_header>
  <id_info>
    <org_study_id>18-009</org_study_id>
    <nct_id>NCT03754426</nct_id>
  </id_info>
  <brief_title>A Prospective, Pilot Evaluation of Device Equivalence</brief_title>
  <acronym>Equivalence</acronym>
  <official_title>Validation of MolecuLight Phoenix Prototypes in Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MolecuLight Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MolecuLight Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with chronic wounds will be imaged using 3 imaging devices. Two types of images will&#xD;
      be acquired with each device, as standard photograph (ST-image) and a fluorescence image&#xD;
      (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5&#xD;
      interpreters to assess for any differences in the images that would alter a clinical&#xD;
      decision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients (n = 50) with chronic wounds will be imaged using 3 imaging devices. Two types of&#xD;
      images will be acquired with each device, as standard photograph (ST-image) and a&#xD;
      fluorescence image (FL-image). The images captured with the 3 imaging devices will be&#xD;
      compared off-line by 5 interpreters to assess for any differences in the images that would&#xD;
      alter a clinical decision.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2018</start_date>
  <completion_date type="Actual">January 2, 2019</completion_date>
  <primary_completion_date type="Actual">January 2, 2019</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>Concordance</measure>
    <time_frame>2 months</time_frame>
    <description>Estimate concordance of moderate/heavy bacterial load present in images acquired with each of 3 devices</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Wound</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fluorescence Imaging Device</intervention_name>
    <description>Hand-held, real-time fluorescence imaging device</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with chronic wounds&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects (inpatient/outpatient) presenting with a wound&#xD;
&#xD;
          -  Wound size less than 15 cm in length&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with an investigational drug within 1 month before study enrolment&#xD;
&#xD;
          -  Subjects with recent (&lt;30 days) biopsy or curettage of target wound&#xD;
&#xD;
          -  Subjects with wounds that cannot be completely imaged by study device due to anatomic&#xD;
             location&#xD;
&#xD;
          -  Unable or unwilling to consent&#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>Ron Linden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Judy Dan Research and Treatment Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Judy Dan Research and Treatment Centre</name>
      <address>
        <city>North York</city>
        <state>Ontario</state>
        <zip>M2R 1N5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 29, 2019</last_update_submitted>
  <last_update_submitted_qc>November 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to disseminate information to patients. If patients ask for their information then they will be provided a response with the most up to date information.</ipd_description>
  </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/NCT03754426
org study id: 18-009
nct id: NCT03754426
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Patients with chronic wounds will be imaged using 3 imaging devices. Two types of images will
      be acquired with each device, as standard photograph (ST-image) and a fluorescence image
      (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5
      interpreters to assess for any differences in the images that would alter a clinical
      decision.
Patients (n = 50) with chronic wounds will be imaged using 3 imaging devices. Two types of
      images will be acquired with each device, as standard photograph (ST-image) and a
      fluorescence image (FL-image). The images captured with the 3 imaging devices will be
      compared off-line by 5 interpreters to assess for any differences in the images that would
      alter a clinical decision.
observational model: Cohort
time perspective: Prospective
measure: Concordance
time frame: 2 months
description: Estimate concordance of moderate/heavy bacterial load present in images acquired with each of 3 devices
intervention type: Device
intervention name: Fluorescence Imaging Device
description: Hand-held, real-time fluorescence imaging device
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ron Linden, MD
role: Principal Investigator
affiliation: Judy Dan Research and Treatment Centre
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No
ipd description: There is no plan to disseminate information to patients. If patients ask for their information then they will be provided a response with the most up to date information.