Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition

August 10, 2009 updated by: Akern USA LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Florence
      • D'Annunzio, Florence, Italy, 50135
        • Laboratorio, FIGC, Settore Tecnico Coverciano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy individuals

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Akern EFG
Device: Akern USA EFG
Impedance measurement device
Active Comparator: RJL device
Device: RJL Impedance analyzer
Impedance analyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resistance (R) - (ohms)
Time Frame: 5 minutes
5 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akern USA LLC

Investigators

  • Principal Investigator: Luca Gatteschi, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

August 8, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2009

Last Update Submitted That Met QC Criteria

August 10, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • EFG001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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