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NCT04006899 Clinical Trial

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

Medical Device Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04006899
Other study ID # GSU001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 20, 2018
Est. completion date May 30, 2019

Study information
Verified date July 2019
Source Georgia Southern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date May 30, 2019
Est. primary completion date May 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Students from Georgia Southern University

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Bioelectrical Impedance Monitor
Subjects had been under the test of three commercially available devices and the device that the investigators had developed.

Locations
Country Name City State
United States Georgia Southern University Statesboro Georgia

Sponsors (1)
Lead Sponsor Collaborator
Jun Choi

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Impedance values from each devices Bioelectrical impedance values from three devices were measured and recorded. One year IRB period
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