<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/NCT03290690</url>
  </required_header>
  <id_info>
    <org_study_id>16-102</org_study_id>
    <nct_id>NCT03290690</nct_id>
  </id_info>
  <brief_title>Positive Predictive Value (PPV) of Pseudomonas Aeruginosa</brief_title>
  <official_title>A Prospective, Single-blind Evaluation of the Positive Predictive Value (PPV) of the MolecuLight i:X™ Imaging Device to Predict the Presence of Pseudomonas Aeruginosa in Chronic Wounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MolecuLight Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Scarborough Rouge Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a non-randomized, single-blind post market clinical follow-up study for which 65&#xD;
      patients will be imaged at Rouge Valley Centenary Hospital (Scarborough and Rouge Hospital)&#xD;
      who present with a chronic wound and are receiving standard wound care treatment. The&#xD;
      MolecuLight i:X imaging device will be used by the study clinician as an adjunctive tool in&#xD;
      the assessment of the wound and will be used to guide the targeted sampling of a wound (with&#xD;
      curettage scraping), as per current standard of care in the principal investigator's wound&#xD;
      care clinic. The acquired tissue sample will then be analysed using conventional gold&#xD;
      standard semi-quantitative culture methods to determine bacterial species present, also as&#xD;
      per current standard of care in this clinic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 4, 2017</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2020</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>Evaluate the ability of the MolecuLight i:X Imaging Device to predicting the presence of Pseudomonas aeruginosa in chronic wounds</measure>
    <time_frame>1 hour</time_frame>
    <description>Primary endpoint: correlation of localized cyan fluorescence signals in device acquired images with microbiological samples indicating Pseudomonas aeruginosa</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">65</enrollment>
  <condition>Wound</condition>
  <condition>Chronic Leg Ulcer</condition>
  <condition>Wound Contamination</condition>
  <arm_group>
    <arm_group_label>All Subjects</arm_group_label>
    <description>All subjects in this study will have their wounds imaged and assessed in the following manner:&#xD;
Capture and save ST-image Capture and save FL-image Identify discrete locations of cyan (blue/green) fluorescent bacteria (FL_C) Acquire sample of tissue where cyan fluorescent bacteria are present (using curette method) Consent patient for inclusion in this study Note location of sample acquisition by annotating FL-image obtained in step 2 Send sample for microbiology analysis Note naming of microbiology sample on Case Report Form</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be treated at the Scarborough and Rouge Hospital as per the standard of care,&#xD;
        which includes use of the MolecuLight i:X imaging device and targeted sampling of regions&#xD;
        with bacterial fluorescence for microbiological analysis. Patients will be identified as&#xD;
        candidates and consented by the study's principle investigator. The images which would be&#xD;
        acquired for this study are currently part of the routine clinical wound care assessment&#xD;
        process in the principle investigator's wound care clinic. However, during study enrollment&#xD;
        subjects will be given as much time as required for their understanding of the basic study,&#xD;
        to understand that their participation is optional, to understand that they will receive&#xD;
        standard of care wound treatment whether or not they choose to participate, and to have any&#xD;
        potential questions addressed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients presenting with a chronic wound (wound duration &gt; 4 weeks)&#xD;
             e.g. diabetic foot ulcer, venous leg ulcer, pressure ulcer, or other acceptable&#xD;
             aetiology&#xD;
&#xD;
          2. 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treatment with an investigational drug within 1 month before study enrolment&#xD;
&#xD;
          2. Inability to consent to medical photography (i.e. inability to understand consent&#xD;
             process)&#xD;
&#xD;
          3. Any contra-indication to routine wound care and/or monitoring&#xD;
&#xD;
          4. Prior participation of the patient in this study (for the same wound or a different&#xD;
             wound).&#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>Rose Raizman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scarborough Rouge Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liis Teene</last_name>
    <phone>6472551519</phone>
    <email>lteene@moleculight.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rose Raizman</last_name>
    <phone>416-886-2328</phone>
    <email>rraizman@rougevalley.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Scarborough and Rouge Hospital</name>
      <address>
        <city>Scarborough</city>
        <state>Ontario</state>
        <zip>M1E 4B9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rose Raizman, RN-EC</last_name>
      <phone>416-886-2328</phone>
      <email>rraizman@rougevalley.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>March 4, 2020</last_update_submitted>
  <last_update_submitted_qc>March 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2020</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>Leg Ulcer</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03290690
org study id: 16-102
nct id: NCT03290690
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a non-randomized, single-blind post market clinical follow-up study for which 65
      patients will be imaged at Rouge Valley Centenary Hospital (Scarborough and Rouge Hospital)
      who present with a chronic wound and are receiving standard wound care treatment. The
      MolecuLight i:X imaging device will be used by the study clinician as an adjunctive tool in
      the assessment of the wound and will be used to guide the targeted sampling of a wound (with
      curettage scraping), as per current standard of care in the principal investigator's wound
      care clinic. The acquired tissue sample will then be analysed using conventional gold
      standard semi-quantitative culture methods to determine bacterial species present, also as
      per current standard of care in this clinic.
observational model: Cohort
time perspective: Prospective
measure: Evaluate the ability of the MolecuLight i:X Imaging Device to predicting the presence of Pseudomonas aeruginosa in chronic wounds
time frame: 1 hour
description: Primary endpoint: correlation of localized cyan fluorescence signals in device acquired images with microbiological samples indicating Pseudomonas aeruginosa
arm group label: All Subjects
description: All subjects in this study will have their wounds imaged and assessed in the following manner:
Capture and save ST-image Capture and save FL-image Identify discrete locations of cyan (blue/green) fluorescent bacteria (FL_C) Acquire sample of tissue where cyan fluorescent bacteria are present (using curette method) Consent patient for inclusion in this study Note location of sample acquisition by annotating FL-image obtained in step 2 Send sample for microbiology analysis Note naming of microbiology sample on Case Report Form
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rose Raizman
role: Principal Investigator
affiliation: Scarborough Rouge Hospital
last name: Liis Teene
phone: 6472551519
email: lteene@moleculight.com
last name: Rose Raizman
phone: 416-886-2328
email: rraizman@rougevalley.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Leg Ulcer
mesh term: Wounds and Injuries
sharing ipd: No