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Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition

This study has been completed.
Information provided by:
Akern USA LLC Identifier:
First received: August 8, 2009
Last updated: August 10, 2009
Last verified: August 2009
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.

Condition Intervention
Body Composition Measurement
Device: Akern USA EFG
Device: RJL Impedance analyzer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Impedance Components and Estimated Body Composition Variables Determined by Using Bioelectrical Impedance Devices Manufactured by Akern SRL and RJL Systems

Further study details as provided by Akern USA LLC:

Primary Outcome Measures:
  • Resistance (R) - (ohms) [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fat Free Mass (FFM) [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Total Body Water (TBW) [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Extra Cellular Water [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Fat Mass (FM) [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: May 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Akern EFG Device: Akern USA EFG
Impedance measurement device
Active Comparator: RJL device Device: RJL Impedance analyzer
Impedance analyzer

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.

Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy individuals

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00956917

Laboratorio, FIGC, Settore Tecnico Coverciano
D'Annunzio, Florence, Italy, 50135
Sponsors and Collaborators
Principal Investigator: Luca Gatteschi, MD
  More Information

Responsible Party: Michaeal G. Singer, Akern USA LLC Identifier: NCT00956917     History of Changes
Other Study ID Numbers: EFG001 
Study First Received: August 8, 2009
Last Updated: August 10, 2009
Health Authority: United States: Institutional Review Board processed this record on January 14, 2017