Clinical Trial of Transtek Body Fat Analyzer (GBF-835-N2 & Other 7 Models)
NCT02345109 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2015-01-26
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. 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.
Conditions
- Weight
- Body Fat Disorder
Interventions
- DEVICE
-
Transtek DUT
Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Transtek DUT.
- DEVICE
-
Reference
Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference.
Sponsors & Collaborators
-
West China Hospital
collaborator OTHER -
Leo Wang
lead OTHER
Principal Investigators
-
Guoqing Li, Director · Wuhou District Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-12-31
- Primary Completion
- 2014-12-31
- Completion
- 2014-12-31
Countries
- China
Study Locations
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