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| ID | Type | Description | Link |
|---|---|---|---|
| BTS15001 | Other Identifier | BTSInternational |
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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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The clinical protocol of the clinical testing of this device:
Test Purpose:
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.
Target Subject:
The subject database shall contain at least 30 male and 30 female subjects and all above 10 years old.
Test procedures:
Note:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transtek DUT | Experimental | Which measured by DUT: 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. |
|
| Reference | Experimental | Measured by Reference: TRANSTEK® Glass Body Fat Analyzer GBF-1251-B, Tanita® Body Composition Monitor BC-533. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transtek DUT | Device | Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Transtek DUT. |
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| Measure | Description | Time Frame |
|---|---|---|
| BMI (Body Mass Index) | Body Fat, Total Body Water, Muscle Mass, Bone Mass, BMI, calorie, and visceral fat. | 5 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Body Weight | 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guoqing Li, Director | Wuhou District Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhou District Hospital | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Reference | Device | Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference. |
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