Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition

Body Composition Measurement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956917
• Other study ID #: EFG001
• Status: Completed
• Phase: N/A
• First received: August 8, 2009
• Last updated: August 10, 2009
• Start date: May 2009
• Est. completion date: June 2009

Study information

• Verified date: August 2009
• Source: Akern USA LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

Inclusion Criteria:

• Healthy individuals

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Body Composition Measurement

Intervention

Device:
• Akern USA EFG
Impedance measurement device
• RJL Impedance analyzer
Impedance analyzer

Locations

Country	Name	City	State
Italy	Laboratorio, FIGC, Settore Tecnico Coverciano	D'Annunzio	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Akern USA LLC

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resistance (R) - (ohms)		5 minutes	No
Secondary	Fat Free Mass (FFM)		5 minutes	No
Secondary	Total Body Water (TBW)		5 minutes	No
Secondary	Extra Cellular Water		5 minutes	No
Secondary	Fat Mass (FM)		5 minutes	No