Clinical Trail of Transtek Glass Body Fat Analyzer (GBFA)

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

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.

Study Overview

• Status: Completed
• Conditions: Weight; Body Fat Disorder; Bone Mass
• Intervention / Treatment: Device: Comparison test

Detailed 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%.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Zhongshan, Guangdong, China, 528403
      • Zhongshan City People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The subject population included patients whose age is above 18 years old. Male or Female.

Description

Inclusion Criteria:

• male,female

Exclusion Criteria:

• below 18 years old

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Body Analysis	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.; Other Names: Brand name: Transtek

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verify the accuracy of measure functions of device	Verify the functions and efficiency of these devices compare with a specified product.	8 days

Collaborators and Investigators

• Sponsor: Leo Wang
• Collaborators: BTS International
• Investigators: Principal Investigator: Stephen Feng, Director, Zhongshan People's Hospital, Guangdong, China

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: September 25, 2011
• First Submitted That Met QC Criteria: September 25, 2011
• First Posted (Estimate): September 27, 2011

Study Record Updates

• Last Update Posted (Estimate): September 27, 2011
• Last Update Submitted That Met QC Criteria: September 25, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: muscle mass; bone mass; weight; total body water; body fat
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: TranstekGBFA11003; BTS-TRANS03 (Other Identifier: BTSInternational)