Wuhou District Hospital
Chengdu, Sichuan, 610041, China
NCT Number: NCT02345109
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. 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. 4. Comparison device: TRANSTEK GBF-1251-B and Tanita BC-533. 5. Study endpoints: DUT and the comparison device are substantial equivalence. 6. Statistical methodology used: Description of statistical methods.
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Notify Me10 year and older
All sexes
Interventional
Not applicable
Chengdu, Sichuan, 610041, China
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.
The subject database shall contain at least 30 male and 30 female subjects and all above 10 years old.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie.
Measure each participants by Transtek DUT.
Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference.
Time frame: 5 Days
Body Fat, Total Body Water, Muscle Mass, Bone Mass, BMI, calorie, and visceral fat.
Time frame: 1 Day
Body Weight
Leo Wang
Other
Verify the Functions and Efficiency of Transtek (Trade Mark) Body Fat Analyzer, 8 Models
Acronym: 15001Analy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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