WeightGBANCT01296048
Clinical Test for Transtek Glass Body Analyzer
An observational study of 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. DUT: Transtek Glass Body Analyzer, Model: GBF-830, GBF-835, GBF-950, and SA-15. 4. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight, Body Fat Disorder, Bone Mass
- What is being tested?
- Comparison test
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Dec 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subject population included patients whose age is above 18 years old. Male or Female.
Who may be able to join
- male,female
Who cannot join
- below 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verify the Functions and Efficiency of Transtek Glass Body Analyzer, GBF-830, GBF-835, GBF-950, SA-15
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.
- DUT: Transtek Glass Body Analyzer, Model: GBF-830, GBF-835, GBF-950, and SA-15.
- Comparison device: Scaleman Body Fat Scales, FS-148BW1 (Predicate Device).
- Study endpoints: Transtek devices and the predicate device are substantial equivalence.
- Statistical methodology used: Description of statistical methods.
- Result: Efficiencies of Transtek devices and predicate device are in the same level.
Read the detailed description
Hospital Information The data was collected by West China Medical College Clinical Investigator Team at Wuhou District Hospital, No. 9 Tongzilin Road, Wuhou District, Chengdu 610041, P. R. China.
Investigator: Catharine Zhang, Nurse A; Vivian Luo, Nurse B; Dr. James Zhu, Sponsor.
Contact Dr. James Zhu Tel: +86 1330 8036568 Used Equipments DUT (Device Under Test): Transtek Glass Body Analyzer, GBF-830, GBF-835, GBF-950, and SA-15.
Reference Device: Scaleman Body Fat Scales, FS-148BW1 (Predicate Device). Test Protocol
- Test Purpose: The aim of clinical test is to collect weight, body fat, total body water, bone mass, and muscle mass reading value which measured by DUT and reference device. Note: GBF-835 has not total body water, bone mass, and muscle mass functions. So it just collects weight and body fat data.
- Target Subject: The subject database shall contain at least 25 male and 25 female subjects and all above 18 years old. Patient's population analysis is bellow.
- Test procedures 1) Record the name, age, gender, and height of each subject. 2) Let subject seated calmly for two minutes before test, dry the feet. 3) 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. 5) Repeat step 1) to 4) for every device (DUT: GBF-830, GBF-835, GBF-950, and SA-15; and reference device: FS-148BW1).
- Repeat step 1) to 5) for each subject. 5. Note:
- No motion and speaking are allowed during the measurement.
- All DUT use the same algorithms, have the same number of electrodes and contact the patient at the same body locations (feet), and operate on the same frequency.
- Test environment: Temperature: 20±1℃; Relative humidity: 40~50%.
- Conditions
- Weight, Body Fat Disorder, Bone Mass
- Being tested
- Comparison test
- Keywords
- weight, body fat, total body water, bone mass, muscle mass
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison testDevice
Also called Brand names: Scaleman, Serial numbers: SBFS1002-351, Code name: FS-148BW1
Scaleman Body Fat Scales, FS-148BW1, accuracy: ±0.1kg and range: 0-180kg.
| Study group | Role | What they receive |
|---|---|---|
| Body Analysis | Not described Receives: Device: Comparison test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verify the accuracy of measure functions of device
Verify the functions and efficiency of these devices compare with a specified product.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2010
- Study completionDec 2010
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 74 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
- NCT01296048
- Sponsor's protocol ID
- Transtek GBA
- Other IDs
- BTS-TRANS02
- Acronym
- GBA
- Status last verified
- Dec 2011
- First submitted
- 12 Feb 2011
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verify the Functions and Efficiency of Transtek Glass Body Analyzer, GBF-830, GBF-835, GBF-950, SA-15
- ClinicalTrials.gov ID
- NCT01296048
- Acronym / sponsor ID
- GBA / Transtek GBA
- Conditions
- Weight, Body Fat Disorder, Bone Mass
- Keywords
- weight, body fat, total body water, bone mass, muscle mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Leo WangUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Feb 2011 (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.
- DUT: Transtek Glass Body Analyzer, Model: GBF-830, GBF-835, GBF-950, and SA-15.
- Comparison device: Scaleman Body Fat Scales, FS-148BW1 (Predicate Device).
- Study endpoints: Transtek devices and the predicate device are substantial equivalence.
- Statistical methodology used: Description of statistical methods.
- Result: Efficiencies of Transtek devices and predicate device are in the same level.
Detailed description
Hospital Information The data was collected by West China Medical College Clinical Investigator Team at Wuhou District Hospital, No. 9 Tongzilin Road, Wuhou District, Chengdu 610041, P. R. China.
Investigator: Catharine Zhang, Nurse A; Vivian Luo, Nurse B; Dr. James Zhu, Sponsor.
Contact Dr. James Zhu Tel: +86 1330 8036568 Used Equipments DUT (Device Under Test): Transtek Glass Body Analyzer, GBF-830, GBF-835, GBF-950, and SA-15.
Reference Device: Scaleman Body Fat Scales, FS-148BW1 (Predicate Device). Test Protocol
- Test Purpose: The aim of clinical test is to collect weight, body fat, total body water, bone mass, and muscle mass reading value which measured by DUT and reference device. Note: GBF-835 has not total body water, bone mass, and muscle mass functions. So it just collects weight and body fat data.
- Target Subject: The subject database shall contain at least 25 male and 25 female subjects and all above 18 years old. Patient's population analysis is bellow.
- Test procedures 1) Record the name, age, gender, and height of each subject. 2) Let subject seated calmly for two minutes before test, dry the feet. 3) 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. 5) Repeat step 1) to 4) for every device (DUT: GBF-830, GBF-835, GBF-950, and SA-15; and reference device: FS-148BW1).
- Repeat step 1) to 5) for each subject. 5. Note:
- No motion and speaking are allowed during the measurement.
- All DUT use the same algorithms, have the same number of electrodes and contact the patient at the same body locations (feet), and operate on the same frequency.
- Test environment: Temperature: 20±1℃; Relative humidity: 40~50%.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body Analysis | – | Device: Comparison test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population included patients whose age is above 18 years old. Male or Female.
Key inclusion criteria (1 listed)
- male,female
Key exclusion criteria (1 listed)
- below 18 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 |
|---|---|---|
| Comparison testAlso: Brand names: Scaleman, Serial numbers: SBFS1002-351, Code name: FS-148BW1Scaleman Body Fat Scales, FS-148BW1, accuracy: ±0.1kg and range: 0-180kg. | Device | Body Analysis |
Primary outcome
Verify the accuracy of measure functions of device
Time frame: 10 days
Verify the functions and efficiency of these devices compare with a specified product.
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 23 Dec 2011.
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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?
An observational study of 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 23 Dec 2011. 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?
Verify the accuracy of measure functions of device (time frame: 10 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 23 Dec 2011.