NCT04466501已完成不适用
A Comparative, Controlled Study to Evaluate the Performance of the ACR | LAB Urine Analysis Test System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 6
- 主要终点
- Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users.
研究概览
简要总结
The ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The test is for the qualitative and semi- quantitative detection of Albumin, Creatinine, and the Albumin-to- Creatinine Ratio. The device is composed of a kit and a smartphone application using an image recognition algorithm.
The degree of agreement of the ACR | LAB as compared to the comparator device will be tested. Urine samples will be tested by a separate professional user on each device.
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
- •Men and women 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 albumin:
- •Diabetes Type I/Type II,
- •Hypertension,
- •Any kidney disease,
- •Other relevant conditions.
- •Subjects with any pathological findings which might be identified by the urine test (according to the physician discretion);
- •Subject is capable and willing to provide informed consent;
- •Subject has facility with both hands
- •Subject is capable and willing to adhere to the study procedures.
排除标准
- 未提供
结局指标
主要结局
Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users.
时间窗: 11 months
次要结局
未报告次要终点
研究者
研究点 (6)
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