<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/NCT04406454</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01-001A</org_study_id>
    <nct_id>NCT04406454</nct_id>
  </id_info>
  <brief_title>The Application of Non-invasive and Cellular Level Resolution Fullfield Optical Coherence Tomography: Establishment and Analysis of Subcutaneous Cellular Level Image Database of Anatomical Locations in Healthy Volunteers and Evaluation of Usability</brief_title>
  <official_title>The Application of Non-invasive and Cellular Level Resolution Fullfield Optical Coherence Tomography: Establishment and Analysis of Subcutaneous Cellular Level Image Database of Anatomical Locations in Healthy Volunteers and Evaluation of Usability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Apollo Medical Optics, Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      ApolloVue® S100 Image System is a medical device class II. The objective of this protocol is&#xD;
      to image skin of healthy volunteers and to evaluate the performance of full-field optical&#xD;
      coherence tomography (FF-OCT) device - the ApolloVue® S100 Image System in imaging skin&#xD;
      microstructures of healthy skin at different anatomical locations and nevi for different skin&#xD;
      types and different age and to evaluate usability of the ApolloVue® S100 Image System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The OCT can provide cellular resolution (~1μm in lateral and axial directions) images. A&#xD;
      cellular resolution OCT has the characteristics of non-invasive, non-radioactive, labelfree,&#xD;
      real-time and high tissue penetration depth that are highly valuable for clinical use. This&#xD;
      technology allows visualization of important structural features such as the epidermis and&#xD;
      dermis and the epidermal-dermal junction. OCT has the advantage of generating cross-sectional&#xD;
      images, like the orientation of pathology slides.&#xD;
&#xD;
      The ApolloVue® S100 Image System is intended to be used as a non-invasive imaging tool in the&#xD;
      evaluation of external human skin tissue microstructure by providing two-dimensional,&#xD;
      crosssectional (B-scan) and en face (E-scan) real-time visualization for assessment by&#xD;
      physicians to support in forming a clinical judgment. For the ApolloVue® S100 Image System&#xD;
      image, both cross-sectional view and en face view can be obtained to assist physicians'&#xD;
      diagnosis. With both views, physicians can obtain important spatial information in regards to&#xD;
      the skin. Besides, the ApolloVue® S100 Image System is equipped with an image guiding system&#xD;
      which provides a high-resolution dermatoscope like image, for the positioning of skin sites&#xD;
      for optical biopsies.&#xD;
&#xD;
      In this protocol, it is proposed to study the optical imaging features of healthy human skin&#xD;
      and nevi and the evaluation of usability. We propose to recruit 60 subjects for such a trial.&#xD;
      Healthy volunteers will be approached and consented to this protocol. The volunteers will be&#xD;
      imaged.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</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>Determine the average scanning success rate of obtaining at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively.</measure>
    <time_frame>2 years</time_frame>
    <description>Scanning efficiency = total number of quality images/total number of images obtained x 100%.&#xD;
Scanning efficiency ≧ 50%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluator identification of each feature will be assessed (number of correctly identified feature/number of total features x 100%).</measure>
    <time_frame>2 years</time_frame>
    <description>The purpose of this evaluation is to validate that the ApolloVue® S100 Image System delivers non-invasive skin image features.&#xD;
Required features will be analyzed for each group, including age, skin type and anatomical location.&#xD;
The features need to meet the following requirement in each 500 x 400 µm2 image for B-scan and in each 500 x 500 μm2 image for E-scan.&#xD;
A. Identification of keratinocyte in ≧ 80% of images (B-scan only)&#xD;
B. Identification of stratum corneum in ≧ 80% of images&#xD;
C. Identification of epidermis in ≧ 80% of images&#xD;
D. Identification of dermis in ≧ 80% of images&#xD;
E. Identification of EDJ in ≧ 80% of images&#xD;
F. Identification of collagen in ≧ 80% of images (B-scan only)&#xD;
G. Identification of melanin in ≧ 80% of images</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine time required to obtain at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively.</measure>
    <time_frame>2 years</time_frame>
    <description>Time required &lt; 20 minutes for each body site except for nevus.&#xD;
Time required &lt; 40 minutes for a nevus including image guiding.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Healthy Skin</condition>
  <condition>Nevus</condition>
  <arm_group>
    <arm_group_label>Heathy volunteers</arm_group_label>
    <description>Patients has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, calf and at least a nevus without superficial scales and crusting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ApolloVue® S100 Image System</intervention_name>
    <description>The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 3 quality OCT images of B-scan (cross-section) and E-scan (en face) with 4 depths for each skin site respectively for each skin site. There is a total of 6 skin sites.</description>
    <arm_group_label>Heathy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population from healthy volunteers will be selected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All age will be recruited.&#xD;
&#xD;
          2. Both genders will be recruited.&#xD;
&#xD;
          3. All skin types will be recruited. Skin type I-VI (Fitzpatrick scale)&#xD;
&#xD;
               -  Type I always burns, never tans (unexposed skin color: white)&#xD;
&#xD;
               -  Type II usually burns, tans less than average (with difficulty) (unexposed skin&#xD;
                  color: white)&#xD;
&#xD;
               -  Type III sometimes mild burns, tans about average (unexposed skin color: white)&#xD;
&#xD;
               -  Type IV rarely burns, tans more than average (with easy) (unexposed skin color:&#xD;
                  white)&#xD;
&#xD;
               -  Type V very rarely burns (unexposed skin color: brown)&#xD;
&#xD;
               -  Type VI never burns (unexposed skin color: black)&#xD;
&#xD;
          4. Has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar&#xD;
             forearm, and calf.&#xD;
&#xD;
          5. Has at least a nevus without superficial scales and crusting&#xD;
&#xD;
          6. Willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals who have a systemic skin disorder.&#xD;
&#xD;
          2. Individuals who have a history of severe skin condition&#xD;
&#xD;
          3. Individuals with surgeries/cosmetic surgeries/micro cosmetic surgery (eg. cosmetic&#xD;
             injections and/or laser etc.) on healthy skin at the 5 anatomical locations and nevi&#xD;
             (see inclusion criteria 5) in last 12 months and a physician determine the surgery&#xD;
             will affect outcome of the OCT images.&#xD;
&#xD;
          4. Not willing to cooperate with methods and related procedures of this trial/study&#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>Ding-Dar Lee, M.D., Ph. D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Veterans General Hospital, Taiwan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei city</city>
        <state>Beitou District</state>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.</citation>
    <PMID>3377516</PMID>
  </reference>
  <reference>
    <citation>Adabi S, Hosseinzadeh M, Noei S, Conforto S, Daveluy S, Clayton A, Mehregan D, Nasiriavanaki M. Universal in vivo Textural Model for Human Skin based on Optical Coherence Tomograms. Sci Rep. 2017 Dec 20;7(1):17912. doi: 10.1038/s41598-017-17398-8.</citation>
    <PMID>29263332</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>September 25, 2021</last_update_submitted>
  <last_update_submitted_qc>September 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Optical Coherence Tomograohy</keyword>
  <keyword>Healthy volunteer</keyword>
  <keyword>Non-invasive image system</keyword>
  <keyword>Cellular level resolution</keyword>
  <keyword>Full-Field OCT</keyword>
  <keyword>Nevus</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04406454
org study id: 2020-01-001A
nct id: NCT04406454
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
ApolloVue® S100 Image System is a medical device class II. The objective of this protocol is
      to image skin of healthy volunteers and to evaluate the performance of full-field optical
      coherence tomography (FF-OCT) device - the ApolloVue® S100 Image System in imaging skin
      microstructures of healthy skin at different anatomical locations and nevi for different skin
      types and different age and to evaluate usability of the ApolloVue® S100 Image System.
The OCT can provide cellular resolution (~1μm in lateral and axial directions) images. A
      cellular resolution OCT has the characteristics of non-invasive, non-radioactive, labelfree,
      real-time and high tissue penetration depth that are highly valuable for clinical use. This
      technology allows visualization of important structural features such as the epidermis and
      dermis and the epidermal-dermal junction. OCT has the advantage of generating cross-sectional
      images, like the orientation of pathology slides.

      The ApolloVue® S100 Image System is intended to be used as a non-invasive imaging tool in the
      evaluation of external human skin tissue microstructure by providing two-dimensional,
      crosssectional (B-scan) and en face (E-scan) real-time visualization for assessment by
      physicians to support in forming a clinical judgment. For the ApolloVue® S100 Image System
      image, both cross-sectional view and en face view can be obtained to assist physicians'
      diagnosis. With both views, physicians can obtain important spatial information in regards to
      the skin. Besides, the ApolloVue® S100 Image System is equipped with an image guiding system
      which provides a high-resolution dermatoscope like image, for the positioning of skin sites
      for optical biopsies.

      In this protocol, it is proposed to study the optical imaging features of healthy human skin
      and nevi and the evaluation of usability. We propose to recruit 60 subjects for such a trial.
      Healthy volunteers will be approached and consented to this protocol. The volunteers will be
      imaged.
observational model: Case-Only
time perspective: Prospective
measure: Determine the average scanning success rate of obtaining at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively.
time frame: 2 years
description: Scanning efficiency = total number of quality images/total number of images obtained x 100%.
Scanning efficiency ≧ 50%
measure: Evaluator identification of each feature will be assessed (number of correctly identified feature/number of total features x 100%).
time frame: 2 years
description: The purpose of this evaluation is to validate that the ApolloVue® S100 Image System delivers non-invasive skin image features.
Required features will be analyzed for each group, including age, skin type and anatomical location.
The features need to meet the following requirement in each 500 x 400 µm2 image for B-scan and in each 500 x 500 μm2 image for E-scan.
A. Identification of keratinocyte in ≧ 80% of images (B-scan only)
B. Identification of stratum corneum in ≧ 80% of images
C. Identification of epidermis in ≧ 80% of images
D. Identification of dermis in ≧ 80% of images
E. Identification of EDJ in ≧ 80% of images
F. Identification of collagen in ≧ 80% of images (B-scan only)
G. Identification of melanin in ≧ 80% of images
measure: Determine time required to obtain at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively.
time frame: 2 years
description: Time required < 20 minutes for each body site except for nevus.
Time required < 40 minutes for a nevus including image guiding.
arm group label: Heathy volunteers
description: Patients has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, calf and at least a nevus without superficial scales and crusting.
intervention type: Device
intervention name: ApolloVue® S100 Image System
description: The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 3 quality OCT images of B-scan (cross-section) and E-scan (en face) with 4 depths for each skin site respectively for each skin site. There is a total of 6 skin sites.
arm group label: Heathy volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ding-Dar Lee, M.D., Ph. D
role: Principal Investigator
affiliation: Taipei Veterans General Hospital, Taiwan
facility: 
country: Taiwan
citation: Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
PMID: 3377516
citation: Adabi S, Hosseinzadeh M, Noei S, Conforto S, Daveluy S, Clayton A, Mehregan D, Nasiriavanaki M. Universal in vivo Textural Model for Human Skin based on Optical Coherence Tomograms. Sci Rep. 2017 Dec 20;7(1):17912. doi: 10.1038/s41598-017-17398-8.
PMID: 29263332
responsible party type: Sponsor
sharing ipd: Undecided