Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition

Akern

Status: Completed

Conditions: Body Composition Measurement

Treatments: Device: RJL Impedance analyzer; Device: Akern USA EFG

Study type: Interventional

Funder types: Industry

Identifiers

NCT00956917

EFG001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 16 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy individuals

Exclusion criteria

• None

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

Akern EFG

Active Comparator group

Treatment:

Device: Akern USA EFG

RJL device

Active Comparator group

Treatment:

Device: RJL Impedance analyzer