Medical DeviceNCT04006899
Development of a Segmental Bioelectrical Impedance Spectroscopy Device for Body Composition Measurement
An observational study of Medical Device, run by Jun Choi at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Device
- What is being tested?
- Bioelectrical Impedance Monitor
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2018to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Students from Georgia Southern University
Who may be able to join
- Students from Georgia Southern University
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Southern University
Statesboro, Georgia, 30459
About this study
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.
Read the detailed 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.
- Conditions
- Medical Device
- Being tested
- Bioelectrical Impedance Monitor
- Keywords
- Bioelectrical Impedance spectroscopy, Body compositions, Segmental Bioelectrical impedance spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectrical Impedance MonitorDevice
Subjects had been under the test of three commercially available devices and the device that the investigators had developed.
| Study group | Role | What they receive |
|---|---|---|
| subj 1 | Three commercially available BIA devices vs SBIS device Receives: Device: Bioelectrical Impedance Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impedance values from each devices
Bioelectrical impedance values from three devices were measured and recorded.
Measured: One year IRB period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start20 Jun 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Choi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Choi, Georgia Southern University
- Investigators
- junghun choi, Ph.D., Principal investigator, Georgia Southern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006899
- Sponsor's protocol ID
- GSU001
- Status last verified
- Jul 2019
- First submitted
- 28 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Segmental Bioelectrical Impedance Spectroscopy Device for Body Composition Measurement
- ClinicalTrials.gov ID
- NCT04006899
- Acronym / sponsor ID
- GSU001
- Conditions
- Medical Device
- Keywords
- Bioelectrical Impedance spectroscopy, Body compositions, Segmental Bioelectrical impedance spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Jun ChoiUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subj 1 | – | Device: Bioelectrical Impedance MonitorThree commercially available BIA devices vs SBIS device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Students from Georgia Southern University
Key inclusion criteria (1 listed)
- Students from Georgia Southern University
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioelectrical Impedance MonitorSubjects had been under the test of three commercially available devices and the device that the investigators had developed. | Device | subj 1 |
Primary outcome
Impedance values from each devices
Time frame: One year IRB period
Bioelectrical impedance values from three devices were measured and recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
junghun choi, Ph.D. principal investigator
Georgia Southern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Device, run by Jun Choi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impedance values from each devices (time frame: One year IRB period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.