Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition

This study has been completed.
Sponsor:
Information provided by:
Akern USA LLC
ClinicalTrials.gov Identifier:
NCT00956917
First received: August 8, 2009
Last updated: August 10, 2009
Last verified: August 2009
  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
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.

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy individuals

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Michaeal G. Singer, Akern USA LLC
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on October 21, 2014