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Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956917
First Posted: August 11, 2009
Last Update Posted: August 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Akern USA LLC
  Purpose
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
Intervention Model: Crossover Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Fat Free Mass (FFM) [ Time Frame: 5 minutes ]
  • Total Body Water (TBW) [ Time Frame: 5 minutes ]
  • Extra Cellular Water [ Time Frame: 5 minutes ]
  • Fat Mass (FM) [ Time Frame: 5 minutes ]

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.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthy individuals

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956917


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

Responsible Party: Michaeal G. Singer, Akern USA LLC
ClinicalTrials.gov Identifier: NCT00956917     History of Changes
Other Study ID Numbers: EFG001
First Submitted: August 8, 2009
First Posted: August 11, 2009
Last Update Posted: August 11, 2009
Last Verified: August 2009