Clinical trial NCT01440894: Clinical Trail of Transtek Glass Body Fat Analyzer
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight
Body Fat Disorder
Bone Mass
Keywords: weight
body fat
total body water
bone mass
muscle mass
Lead sponsor: BTS International
Sponsor class: OTHER
Collaborators: name: BTS International
First posted: 2011-09-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subject population included patients whose age is above 18 years old. Male or Female.

Brief 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.

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%.

Eligibility criteria: Inclusion Criteria:

* male,female

Exclusion Criteria:

* below 18 years old

Primary outcomes:
measure: Verify the accuracy of measure functions of device
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zhongshan
country: China
facility: Zhongshan City People's Hospital
state: Guangdong
Study officials:
affiliation: Zhongshan People's Hospital, Guangdong, China
name: Stephen Feng, Director
role: PRINCIPAL_INVESTIGATOR
References: