NCT00956917

Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Akern USA LLC · Industry
• Sex: All
• Age: 16 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Body Composition Measurement

Interventions

Type	Name	Description
DEVICE	Akern USA EFG	Impedance measurement device
DEVICE	RJL Impedance analyzer	Impedance analyzer

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-08-11
• Last updated: 2009-08-11

Locations

1 site across 1 country: Italy