Comparison of Bioimpedance Body Composition Device Measurements

Completed

Conditions studied: Self-declared Healthy Subjects

In brief

A new investigational device (BIA/Vitality Analyzer™) is being compared to a United States Food and Drug Approved 'predicate' reference device (EFG®) to demonstrate that they provide equivalent measurements of body fat. Both devices are "over-the-counter" bioimpedance body composition analyzers (estimate of body fat). These devices are classified as 'Not Significant Risk' devices; they do not expose you to any significant risks.

Key facts

Study ID

NCT01888068

Run by

IPGDx, LLC

People needed

100

Starts

2013-06-01

Expected to finish

2013-07-01

Last updated by the study team

2013-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• self-reported healthy men and women
• 18 to 99 years of age

You may not qualify if…

• Pregnancy
• Pacemaker
• Implanted Electrical Defibrillator

Where it is running

• FL Arm — Nokomis, Florida, United States
• IPGDx, LLC — Harrisville, Michigan, United States

Full record on ClinicalTrials.gov

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