Body Composition Measurement Clinical Trial
Official title:
Comparison of Impedance Components and Estimated Body Composition Variables Determined by Using Bioelectrical Impedance Devices Manufactured by Akern SRL and RJL Systems
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.
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. ;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic