NCT04006899

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

June 28, 2019

Last Update Submit

July 1, 2019

Conditions

Medical Device

Keywords

Bioelectrical Impedance spectroscopyBody compositionsSegmental Bioelectrical impedance spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Impedance values from each devices

    Bioelectrical impedance values from three devices were measured and recorded.

    One year IRB period

Study Arms (1)

subj 1

Three commercially available BIA devices vs SBIS device

Device: Bioelectrical Impedance Monitor

Interventions

Bioelectrical Impedance MonitorDEVICE

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

subj 1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Students from Georgia Southern University

You may qualify if:

  • Students from Georgia Southern University

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Southern University

Statesboro, Georgia, 30459, United States

Location

Study Officials

  • junghun choi, Ph.D.

    Georgia Southern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 5, 2019

Study Start

June 20, 2018

Primary Completion

May 30, 2019

Study Completion

May 30, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)