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OpenTrials
Completed

NCT Number: NCT04006899

Development of a Segmental Bioelectrical Impedance Spectroscopy Device for Body Composition Measurement

A device for measuring body composition with a small electric current, at 200 μA, (bioelectrical impedance analysis, or BIA) was designed. The goal of this study is to validate the device against several existing devices using the same method of measuring body composition with a small electric current.

Completed

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Key information

Conditions

Medical Device

Sex eligibility

All sexes

Study type

Observational

Primary location

Georgia Southern University

Statesboro, Georgia, 30459, United States

About this study

The measurement of individual segments, instead of the body as a whole, with BIA has not been fully explored. The prototype device is capable of directly measuring multiple body segments (arm, trunk, and leg) simultaneously, and the final version will be able to provide composition about each segment and the body as a whole. Current devices on the market are not capable of this.

The reference devices will be used to measure segments as well, and the raw measurements will be compared. The Multiscan 5000 provides segmental body composition for the arm or leg, but requires measuring it separately. The SFB7 is designed only for measuring the whole body, but the raw impedance measurement data from the SFB7 can be used for comparison, as the impedance magnitudes of individual segments will be within its measurement range. The Seca 514 doesn't directly measure segments, but it can provide segmental data by measuring from hand to foot, then from hand to hand, and finally from foot to foot. It then uses these measurements, and assumptions about the subject to provide segmental composition data.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Students from Georgia Southern University

Exclusion criteria

Treatment and study plan

Bioelectrical Impedance Monitor

Device

Subjects had been under the test of three commercially available devices and the device that the investigators had developed.

Primary outcomes

  1. Impedance values from each devices

    Time frame: One year IRB period

    Bioelectrical impedance values from three devices were measured and recorded.

Sponsors and collaborators

Lead sponsor

Jun Choi

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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