NCT02785445
已完成
不适用
A Comparative, Controlled Study to Evaluate the Clinical Accuracy and User Performance of the Dip Home-Based Dipstick Analyzer
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 2
- 主要终点
- Exact and ±1 agreement to compared device
概览
简要总结
The objectives of the Healthy.io Method Comparison and User Performance Study are:
- To evaluate the performance of Dip.io Device in comparison to the ACON U500 Mission® U500 Urine Analyzer.
- To evaluate the user performance of Dip.io Device under actual use conditions (home environment) based on a user questionnaire and rating scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is male or female, 18-80 years of age
- •Subjects who are healthy or pregnant; or
- •Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite (examples of such diseases include the following):
- •diabetes Type I, Type II, or gestational diabetes (Type III) or,
- •urinary tract infection (UTI)
- •heart disease
- •kidney disease
- •liver disease
- •pregnant women with preeclampsia, gestational diabetes or UTI
- •any pathological findings which might be identified by the urine test (according to the physician discretion)
排除标准
- •Subject has dementia.
- •Subject has mental disorders.
- •Subject is visually impaired (cannot read the user manual).
- •Subject cannot collect urine in receptacle.
- •Any other reason that might preclude the subject from the study.
结局指标
主要结局
Exact and ±1 agreement to compared device
时间窗: Through study completion, an average of 1 month
The primary objective of the study is to evaluate the exact agreement and the ±1 color block match of the Dip.io compared to the predicate device, for each analyte concentration (block).
次要结局
- User performance(Through study completion, an average of 1 month)
研究者
研究点 (2)
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