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临床试验/NCT04457375
NCT04457375已完成不适用

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

Nova Southeastern University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Sub-Mental-to-Arm TDC ratio

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Sub-Mental-to-Arm TDC ratio

时间窗: one year

Sub-Mental-to-Arm TDC ratio

Neck-to-Arm TDC ratio

时间窗: one year

Neck-to-Arm TDC ratio

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Harvey Mayrovitz

Professor

Nova Southeastern University

研究点 (1)

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