Body Fat Disorder Clinical Trial
— BS-BTOfficial title:
Verify the Functions and Efficiency of Transtek (Trade Mark) Body Fat Analyzer, GBF-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B
Verified date | January 2013 |
Source | BTS International |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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-1251-B, BF-1255-B,
BF-1256-B, and GBF-1257-B.
4. Comparison device: Transtek, Glass Body Fat Analyzer, GBF-950-D.
5. Study endpoints: DUT and the comparison device are substantial equivalence.
6. Statistical methodology used: Description of statistical methods.
Status | Completed |
Enrollment | 50 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
China | Wuhou District Hospital | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Leo Wang | West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BMI (Body Mass Index) | Body Fat, Total Body Water, Muscle Mass, Bone Mass | 5 Day | No |
Secondary | Weight | Body Weight | 5 Days | No |
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