Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition

NCT ID: NCT00956917

Last Updated: 2009-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Body Composition Measurement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Akern EFG

Group Type ACTIVE_COMPARATOR

Akern USA EFG

Intervention Type DEVICE

Impedance measurement device

RJL device

Group Type ACTIVE_COMPARATOR

RJL Impedance analyzer

Intervention Type DEVICE

Impedance analyzer

Interventions

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Akern USA EFG

Impedance measurement device

Intervention Type DEVICE

RJL Impedance analyzer

Impedance analyzer

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy individuals

Exclusion Criteria

* None
Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Akern USA LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Akern USA LLC

Principal Investigators

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Luca Gatteschi, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Laboratorio, FIGC, Settore Tecnico Coverciano

D'Annunzio, Florence, Italy

Site Status

Countries

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Italy

Other Identifiers

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EFG001

Identifier Type: -

Identifier Source: org_study_id

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