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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00956917

Enrollment

109

Registered

2009-08-11

Start date

2009-05-31

Completion date

2009-06-30

Last updated

2009-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Composition Measurement

Brief 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.

Interventions

DEVICEAkern USA EFG

Impedance measurement device

DEVICERJL Impedance analyzer

Impedance analyzer

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 90 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy individuals

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Resistance (R) - (ohms)	5 minutes

Secondary

Measure	Time frame
Fat Free Mass (FFM)	5 minutes
Total Body Water (TBW)	5 minutes
Extra Cellular Water	5 minutes
Fat Mass (FM)	5 minutes

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026