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临床试验/NCT00956917
NCT00956917已完成不适用

Comparison of Impedance Components and Estimated Body Composition Variables Determined by Using Bioelectrical Impedance Devices Manufactured by Akern SRL and RJL Systems

Akern USA LLC2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2009年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
109
试验地点
2
主要终点
Resistance (R) - (ohms)

研究概览

简要总结

The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance analyzer is comparable to a predicate device in measuring human body composition.

详细描述

The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance analyzer is comparable to a predicate device in measuring human body composition under normal patient conditions. Specifically, the goal of this study is to compare impedance measurements (R and Xc) determined by using each bioelectrical impedance device and the estimated body compositional estimates [total body water (TBW); fat-free mass (FFM); and fat mass (FM)] calculated by using the same prediction equation (models) as the predicate device.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy individuals

排除标准

  • 未提供

结局指标

主要结局

Resistance (R) - (ohms)

时间窗: 5 minutes

次要结局

  • Fat Free Mass (FFM)(5 minutes)
  • Total Body Water (TBW)(5 minutes)
  • Extra Cellular Water(5 minutes)
  • Fat Mass (FM)(5 minutes)

研究者

发起方
Akern USA LLC
申办方类型
Industry

研究点 (2)

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