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| ID | Type | Description | Link |
|---|---|---|---|
| BTS13001 | 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 weight, body fat, total body water, bone mass, and muscle mass reading value which measured by DUT and reference device.
Target Subject:
The subject database shall contain at least 25 male and 25 female subjects and all above 18 years old.
Test procedures:
Note:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transtek 125X | Experimental | Which measured by DUT (Transtek 125X): GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B. |
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| Transtek 950D | Experimental | Measured by Reference (Transtek 950D): GBF-950-D. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transtek 125X | Device | Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 125X (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B). |
| Measure | Description | Time Frame |
|---|---|---|
| BMI (Body Mass Index) | Body Fat, Total Body Water, Muscle Mass, Bone Mass | 5 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Body Weight | 5 Days |
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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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| Transtek 950D | Device | Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 950D (GBF-950-D). |
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