Clinical Trail of Transtek Glass Body Fat Analyzer

Body Fat Disorder Clinical Trial

— GBFA  

Official title:

Verify the Functions and Efficiency of Transtek Glass Body Fat Analyzer, GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, GBF-950-D.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440894
• Other study ID #: TranstekGBFA11003
• Secondary ID: BTS-TRANS03
• Status: Completed
• Phase: N/A
• First received: September 25, 2011
• Last updated: September 25, 2011
• Start date: February 2011
• Est. completion date: February 2011

Study information

• Verified date: September 2011
• Source: BTS International
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical 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(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D.

4. Comparison device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device).

5. Study endpoints: Transtek devices and the predicate device are substantial equivalence.

6. Statistical methodology used: Description of statistical methods.

7. Result: Efficiencies of Transtek devices and predicate device are in the same level.

Description:

Hospital Information The data was collected by Zhongshan City People's Hospital Clinical Investigator Team at Zhongshan City People's Hospital, No.2 Sunwen Dong Road, Zhongshan, Guangdong 528403, P. R. China.

Investigator: Dr. Stephen Feng, Leader; Fan Futao, Nurse A; Wu Yanting, Nurse B.

Contact Dr. James Zhu Tel: +86 760 88823818 Used Equipments DUT (Device Under Test):

Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D.

Reference Device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device). Test Protocol

1. 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-733-W1 and BF-1039 have not bone mass functions. So it just collects weight, body fat, total body water, and muscle mass data.

2. 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.

3. Test procedures 1) Record the name, age, and gender values 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.

4) For each subject, repeat 3) to get 3 pairs measurements. 5) Repeat step 1) to 4) for every device (DUT: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D; and reference device: GBF-950).

6) Repeat step 1) to 5) for each subject. 5. Note:

1. No motion and speaking are allowed during the measurement.

2. 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.

3. Test environment: Temperature: 22±1℃; Relative humidity: 40~50%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male,female

Exclusion Criteria:

• below 18 years old

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Body Fat Disorder
• Bone Mass
• Lipid Metabolism Disorders
• Weight

Intervention

Device:
• Comparison test
Reference Device: Transtek Glass Body Analyzer, GBF-950, accuracy: ±0.1kg and range: 0-180kg. DUT(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D.

Locations

Country	Name	City	State
China	Zhongshan City People's Hospital	Zhongshan	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Leo Wang	BTS International

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verify the accuracy of measure functions of device	Verify the functions and efficiency of these devices compare with a specified product.	8 days	Yes

External Links

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