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Completed

NCT Number: NCT00956917

Comparison Study for Bioelectrical Impedance Device to Measure 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.

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Key information

Conditions

Body Composition Measurement

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratorio, FIGC, Settore Tecnico Coverciano

D'Annunzio, Florence, 50135, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy individuals

Exclusion criteria

  • None

Treatment and study plan

Akern USA EFG

Device

Impedance measurement device

RJL Impedance analyzer

Device

Impedance analyzer

Primary outcomes

  1. Resistance (R) - (ohms)

    Time frame: 5 minutes

Secondary outcomes

  1. Fat Free Mass (FFM)

    Time frame: 5 minutes

  2. Total Body Water (TBW)

    Time frame: 5 minutes

  3. Extra Cellular Water

    Time frame: 5 minutes

  4. Fat Mass (FM)

    Time frame: 5 minutes

Sponsors and collaborators

Lead sponsor

Akern USA LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 11, 2009
Registry last updated
Aug 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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