Verify the Functions and Efficiency of Transtek Glass Body Analyzer, GBF-830, GBF-835, GBF-950, SA-15
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Verify the accuracy of measure functions of device
研究概览
简要总结
The clinical protocol of the clinical testing of this device:
- Objective of the test: To verify the functions and efficiency of devices.
- Test methods and procedures: Comparison Test.
- DUT: Transtek Glass Body Analyzer, Model: GBF-830, GBF-835, GBF-950, and SA-15.
- Comparison device: Scaleman Body Fat Scales, FS-148BW1 (Predicate Device).
- Study endpoints: Transtek devices and the predicate device are substantial equivalence.
- Statistical methodology used: Description of statistical methods.
- Result: Efficiencies of Transtek devices and predicate device are in the same level.
详细描述
Hospital Information The data was collected by West China Medical College Clinical Investigator Team at Wuhou District Hospital, No. 9 Tongzilin Road, Wuhou District, Chengdu 610041, P. R. China.
Investigator: Catharine Zhang, Nurse A; Vivian Luo, Nurse B; Dr. James Zhu, Sponsor.
Contact Dr. James Zhu Tel: +86 1330 8036568 Used Equipments DUT (Device Under Test): Transtek Glass Body Analyzer, GBF-830, GBF-835, GBF-950, and SA-15.
Reference Device: Scaleman Body Fat Scales, FS-148BW1 (Predicate Device). Test Protocol
- Test Purpose:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male,female
排除标准
- •below 18 years old
结局指标
主要结局
Verify the accuracy of measure functions of device
时间窗: 10 days
Verify the functions and efficiency of these devices compare with a specified product.
次要结局
未报告次要终点
研究者
Leo Wang
Team Leader
BTS International