<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/NCT04457375</url>
  </required_header>
  <id_info>
    <org_study_id>2019-595-NSU</org_study_id>
    <nct_id>NCT04457375</nct_id>
  </id_info>
  <brief_title>Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema</brief_title>
  <official_title>Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Southeastern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Southeastern University</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>
      Selected measurements in healthy persons of skin tissue dielectric constant as reference&#xD;
      values for subsequent use to evaluate patients with head and neck lymphedema.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Skin tissue dielectric constant (TDC) measurements will non-invasively be made bilaterally at&#xD;
      two neck sites, bilaterally on two forearm sites and one site at the chin sub-mental area.&#xD;
&#xD;
      Measurements are made with subjects fully clothed and seated. Measurements are made in&#xD;
      triplicate and averaged at each site. Full measurements take about 5-7 minutest to complete.&#xD;
      Data will be analyzed to determine the neck-to-arm ratios and chin-to-arm ratios to establish&#xD;
      normal ranges of these parameters for subsequent use as comparisons to evaluate and track&#xD;
      changes in patients with head and neck lymphedema.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2020</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">January 15, 2021</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>Neck-to-Arm TDC ratio</measure>
    <time_frame>one year</time_frame>
    <description>Neck-to-Arm TDC ratio</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sub-Mental-to-Arm TDC ratio</measure>
    <time_frame>one year</time_frame>
    <description>Sub-Mental-to-Arm TDC ratio</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bilateral values and Variability in TDC values</measure>
    <time_frame>one year</time_frame>
    <description>Bilateral values and Variability in TDC values</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Lymphedema, Secondary</condition>
  <arm_group>
    <arm_group_label>Healthy Adults</arm_group_label>
    <description>Healthy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>TDC</intervention_name>
    <description>measurements</description>
    <arm_group_label>Healthy Adults</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy with no current or past skin conditions affecting neck or arms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known to have diabetes of any type.&#xD;
&#xD;
          2. Having facial or neck hair that prohibits accurate measurements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nova Southeastern University</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 7, 2021</last_update_submitted>
  <last_update_submitted_qc>June 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nova Southeastern University</investigator_affiliation>
    <investigator_full_name>Harvey Mayrovitz</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>tissue dielectric constant</keyword>
  <keyword>head and neck lymphedema</keyword>
  <keyword>lymphedema</keyword>
  <keyword>reference values</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Lymphedema</mesh_term>
  </condition_browse>
  <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/NCT04457375
org study id: 2019-595-NSU
nct id: NCT04457375
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Selected measurements in healthy persons of skin tissue dielectric constant as reference
      values for subsequent use to evaluate patients with head and neck lymphedema.
Skin tissue dielectric constant (TDC) measurements will non-invasively be made bilaterally at
      two neck sites, bilaterally on two forearm sites and one site at the chin sub-mental area.

      Measurements are made with subjects fully clothed and seated. Measurements are made in
      triplicate and averaged at each site. Full measurements take about 5-7 minutest to complete.
      Data will be analyzed to determine the neck-to-arm ratios and chin-to-arm ratios to establish
      normal ranges of these parameters for subsequent use as comparisons to evaluate and track
      changes in patients with head and neck lymphedema.
observational model: Cohort
time perspective: Prospective
measure: Neck-to-Arm TDC ratio
time frame: one year
description: Neck-to-Arm TDC ratio
measure: Sub-Mental-to-Arm TDC ratio
time frame: one year
description: Sub-Mental-to-Arm TDC ratio
measure: Bilateral values and Variability in TDC values
time frame: one year
description: Bilateral values and Variability in TDC values
arm group label: Healthy Adults
description: Healthy
intervention type: Diagnostic Test
intervention name: TDC
description: measurements
arm group label: Healthy Adults
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Nova Southeastern University
investigator full name: Harvey Mayrovitz
investigator title: Professor
mesh term: Head and Neck Neoplasms
mesh term: Lymphedema
sharing ipd: Undecided