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Clinical Trials/NCT04457375
NCT04457375
Completed
Not Applicable

Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema

Nova Southeastern University1 site in 1 country70 target enrollmentJanuary 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lymphedema, Secondary
Sponsor
Nova Southeastern University
Enrollment
70
Locations
1
Primary Endpoint
Sub-Mental-to-Arm TDC ratio
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Selected measurements in healthy persons of skin tissue dielectric constant as reference values for subsequent use to evaluate patients with head and neck lymphedema.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 16, 2020
End Date
January 15, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Harvey Mayrovitz

Professor

Nova Southeastern University

Eligibility Criteria

Inclusion Criteria

  • Healthy with no current or past skin conditions affecting neck or arms

Exclusion Criteria

  • Known to have diabetes of any type.
  • Having facial or neck hair that prohibits accurate measurements

Outcomes

Primary Outcomes

Sub-Mental-to-Arm TDC ratio

Time Frame: one year

Sub-Mental-to-Arm TDC ratio

Neck-to-Arm TDC ratio

Time Frame: one year

Neck-to-Arm TDC ratio

Secondary Outcomes

  • Bilateral values and Variability in TDC values(one year)

Study Sites (1)

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