xml: <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/NCT06024512</url>
    </required_header>
    <id_info>
      <org_study_id>CLA-PR-01</org_study_id>
      <nct_id>NCT06024512</nct_id>
    </id_info>
    <brief_title>DeepView Snapshot Handheld (DV-H) Comparison Study</brief_title>
    <acronym>DHA</acronym>
    <official_title>DeepView Snapshot Handheld (DV-H) Comparison Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>SpectralMD</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>SpectralMD</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_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        his study is being done to collect pictures of burns using an investigational device called&#xD;
        the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected&#xD;
        will be used to assess the performance of the DV-H device, and to determine the device's&#xD;
        ability to differentiate healing versus non-healing burn tissue. This device, if approved, is&#xD;
        expected to give caregivers a better understanding of what parts of burn wounds will likely&#xD;
        not heal on their own and as a tool used by the military in the field. This current study&#xD;
        involves the collection of images over the course of your clinical treatment and follow-up&#xD;
        according to your routine standard of care. The device will not be used to diagnose or&#xD;
        prescribe treatment for your burn&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 13, 2023</start_date>
    <completion_date type="Anticipated">November 10, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 10, 2023</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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>DeepView Snapshot Handheld (DV-SSH) Comparison Study Protocol</measure>
      <time_frame>3 months</time_frame>
      <description>The primary objective of this study is to demonstrate that the proposed SA-MSI sensor is equivalent or better than the current LC-MSI sensor.&#xD;
  To conduct this test, we will compare the performance of the burn assessment AI algorithm using the image sensor as input data to the same Algorithm using the lens cluster data as an input.</description>
    </primary_outcome>
    <enrollment type="Anticipated">22</enrollment>
    <condition>Burns</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Burn</intervention_name>
      <description>This study is being done to collect pictures of burns using an investigational device called the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected will be used to assess the performance of the DV-H device, and to determine the device's ability to differentiate healing versus non-healing burn tissue. This device, if approved, is expected to give caregivers a better understanding of what parts of burn wounds will likely not heal on their own and as a tool used by the military in the field. This current study involves the collection of images over the course of your clinical treatment and follow-up according to your routine standard of care. The device will not be used to diagnose or prescribe treatment for your burn.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The goal of this prospective study is to evaluate Study Burns from up to 22 Subjects. Adult&#xD;
          will be defined as Subjects 18 years of age or older.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          .Age &gt;18 years and able to give informed consent or have a Legally Authorized&#xD;
          Representative (LAR) able to do so;&#xD;
  &#xD;
            -  Life expectancy &gt; 6 months;&#xD;
  &#xD;
            -  Thermal burn mechanism (flame, scald, or contact);&#xD;
  &#xD;
            -  The Study Burn(s) occurred less than 72 hours prior to the time of first imaging;&#xD;
  &#xD;
            -  Minimum burn wound size for patients is 0.5% TBSA per region&#xD;
  &#xD;
            -  Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn;&#xD;
               and&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients will be excluded if any of the following conditions apply:&#xD;
  &#xD;
                 -  Burn pattern distribution isolated to head, face, neck, hands, feet, genitalia,&#xD;
                    and/or joints;&#xD;
  &#xD;
                 -  Subject has burns involving &gt; 50% total body surface area (TBSA);&#xD;
  &#xD;
                 -  Sepsis at the time of enrollment determined by diagnosis made by Principal&#xD;
                    Investigator or Sub-Investigator;&#xD;
  &#xD;
                 -  Immunosuppression/radiation/chemotherapy &lt; 3 months prior to enrollment;&#xD;
  &#xD;
                 -  Concurrent use of investigational products with a known effect on the burn sites;&#xD;
                    and/or&#xD;
  &#xD;
                 -  Any condition that in the opinion of the Investigator may prevent compliance with&#xD;
                    the study requirements or compromise subject safety.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Edoe Nyajro, BS</last_name>
      <phone>2818181226</phone>
      <email>nyajro@spectralmd.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>LSU Health New Orleans University Medical Center New Orleans</name>
        <address>
          <city>New Orleans</city>
          <state>Louisiana</state>
          <zip>70112</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shana Lennard, RN</last_name>
        <phone>504-702-5171</phone>
        <email>slenna@lsuhsc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Plan is still in motion.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>1 year</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024512
  org study id: CLA-PR-01
  nct id: NCT06024512
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  his study is being done to collect pictures of burns using an investigational device called
        the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected
        will be used to assess the performance of the DV-H device, and to determine the device's
        ability to differentiate healing versus non-healing burn tissue. This device, if approved, is
        expected to give caregivers a better understanding of what parts of burn wounds will likely
        not heal on their own and as a tool used by the military in the field. This current study
        involves the collection of images over the course of your clinical treatment and follow-up
        according to your routine standard of care. The device will not be used to diagnose or
        prescribe treatment for your burn
  observational model: Case-Only
  time perspective: Other
  measure: DeepView Snapshot Handheld (DV-SSH) Comparison Study Protocol
  time frame: 3 months
  description: The primary objective of this study is to demonstrate that the proposed SA-MSI sensor is equivalent or better than the current LC-MSI sensor.
  To conduct this test, we will compare the performance of the burn assessment AI algorithm using the image sensor as input data to the same Algorithm using the lens cluster data as an input.
  intervention type: Device
  intervention name: Burn
  description: This study is being done to collect pictures of burns using an investigational device called the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected will be used to assess the performance of the DV-H device, and to determine the device's ability to differentiate healing versus non-healing burn tissue. This device, if approved, is expected to give caregivers a better understanding of what parts of burn wounds will likely not heal on their own and as a tool used by the military in the field. This current study involves the collection of images over the course of your clinical treatment and follow-up according to your routine standard of care. The device will not be used to diagnose or prescribe treatment for your burn.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  last name: Edoe Nyajro, BS
  phone: 2818181226
  email: nyajro@spectralmd.com
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Plan is still in motion.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: 1 year