Weight15001AnalyNCT02345109
Clinical Trial of Transtek Body Fat Analyzer (GBF-835-N2 & Other 7 Models)
A study testing Transtek DUT and Reference in people with Weight and Body Fat Disorder, run by Leo Wang at 1 site in China.
Trial summary
The clinical protocol of the clinical testing of this device: 1. Objective of the test: To verify the functions and efficiency of devices. 2. Test methods and procedures: Comparison Test. 3. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight, Body Fat Disorder
- What is being tested?
- Transtek DUT and Reference
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2014
- Phase
- Interventional
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male, female
Who cannot join
- Below 10 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verify the Functions and Efficiency of Transtek (Trade Mark) Body Fat Analyzer, 8 Models
The clinical protocol of the clinical testing of this device:
- Objective of the test: To verify the functions and efficiency of devices.
- Test methods and procedures: Comparison Test.
- Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus.
- Comparison device: TRANSTEK GBF-1251-B and Tanita BC-533.
- Study endpoints: DUT and the comparison device are substantial equivalence.
- Statistical methodology used: Description of statistical methods.
Read the detailed description
- Test Purpose: The aim of clinical test is to collect BMI, body fat, total body water, muscle mass, bone mass, calorie, and visceral fat reading value which measured by DUT and reference device.
- Target Subject: The subject database shall contain at least 30 male and 30 female subjects and all above 10 years old.
- Test procedures:
- Record the name, age, gender, and height of each subject.
- Let subject seated calmly for two minutes before test, dry the feet.
- Use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value.
- For each subject, repeat 3) to get 3 pairs measurements.
- Repeat step 1) to 4) for every device (DUT: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus; and reference device: GBF-1251-B and BC-533).
- Repeat step 1) to 5) for each subject.
- Note:
- No motion and speaking are allowed during the measurement.
- All DUT use the same algorithms and contact the patient at the same body locations (feet), and operate on the same frequency.
- Test environment: Temperature: 22±1℃; Relative humidity: 40~70%.
- Conditions
- Weight, Body Fat Disorder
- Being tested
- Transtek DUT, Reference
- Keywords
- weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, calories
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transtek DUTDevice
Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie.
Measure each participants by Transtek DUT.
ReferenceDevice
Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference.
| Study group | Role | What they receive |
|---|---|---|
| Transtek DUT | Experimental | Which measured by DUT: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, Ls202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus. Receives: Device: Transtek DUT; Device: Reference |
| Reference | Experimental | Measured by Reference: TRANSTEK® Glass Body Fat Analyzer GBF-1251-B, Tanita® Body Composition Monitor BC-533. Receives: Device: Transtek DUT; Device: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI (Body Mass Index)
Body Fat, Total Body Water, Muscle Mass, Bone Mass, BMI, calorie, and visceral fat.
Measured: 5 Days
Secondary outcomes (1)
Weight
Body Weight
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WeightStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leo Wang
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Sponsor-investigator, Leo Wang, BTS International
- Investigators
- Guoqing Li, Director, Principal investigator, Wuhou District Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345109
- Sponsor's protocol ID
- 15001_Analyzer
- Other IDs
- BTS15001
- Acronym
- 15001Analy
- Status last verified
- Jan 2015
- First submitted
- 19 Jan 2015
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verify the Functions and Efficiency of Transtek (Trade Mark) Body Fat Analyzer, 8 Models
- ClinicalTrials.gov ID
- NCT02345109
- Acronym / sponsor ID
- 15001Analy / 15001_Analyzer
- Conditions
- Weight, Body Fat Disorder
- Keywords
- weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, calories
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Leo WangUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- Dec 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Jan 2015 (estimated)
- 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.
The clinical protocol of the clinical testing of this device:
- Objective of the test: To verify the functions and efficiency of devices.
- Test methods and procedures: Comparison Test.
- Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus.
- Comparison device: TRANSTEK GBF-1251-B and Tanita BC-533.
- Study endpoints: DUT and the comparison device are substantial equivalence.
- Statistical methodology used: Description of statistical methods.
Detailed description
- Test Purpose: The aim of clinical test is to collect BMI, body fat, total body water, muscle mass, bone mass, calorie, and visceral fat reading value which measured by DUT and reference device.
- Target Subject: The subject database shall contain at least 30 male and 30 female subjects and all above 10 years old.
- Test procedures:
- Record the name, age, gender, and height of each subject.
- Let subject seated calmly for two minutes before test, dry the feet.
- Use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value.
- For each subject, repeat 3) to get 3 pairs measurements.
- Repeat step 1) to 4) for every device (DUT: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus; and reference device: GBF-1251-B and BC-533).
- Repeat step 1) to 5) for each subject.
- Note:
- No motion and speaking are allowed during the measurement.
- All DUT use the same algorithms and contact the patient at the same body locations (feet), and operate on the same frequency.
- Test environment: Temperature: 22±1℃; Relative humidity: 40~70%.
Study design
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transtek DUT | Experimental | Device: Transtek DUT, Device: ReferenceWhich measured by DUT: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, Ls202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus. |
| Reference | Experimental | Device: Transtek DUT, Device: ReferenceMeasured by Reference: TRANSTEK® Glass Body Fat Analyzer GBF-1251-B, Tanita® Body Composition Monitor BC-533. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Male, female
Key exclusion criteria (1 listed)
- Below 10 years old
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 |
|---|---|---|
| Transtek DUTMeasuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Transtek DUT. | Device | Reference, Transtek DUT |
| ReferenceMeasuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference. | Device | Reference, Transtek DUT |
Primary outcome
BMI (Body Mass Index)
Time frame: 5 Days
Body Fat, Total Body Water, Muscle Mass, Bone Mass, BMI, calorie, and visceral fat.
1 secondary outcome
Weight
Time frame: 1 Day
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 26 Jan 2015.
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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.
Guoqing Li, Director principal investigator
Wuhou District Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transtek DUT and Reference in people with Weight and Body Fat Disorder, run by Leo Wang at 1 site in China.
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 1 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 26 Jan 2015. 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 China. 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?
BMI (Body Mass Index) (time frame: 5 Days). 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 26 Jan 2015.