NCT03965975Unknown不适用
(In Spanish, Spain) "Validación Clínica Mediante Estudio analítico Con Muestras de Orina Para Comparar la Eficacia y Seguridad de un Smart Device"
S-There Technologies SL2 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2019年6月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Accuracy to compared device
研究概览
简要总结
The objectives of the Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device are:
1.To evaluate the performance of S-There Device in comparison to the golden standard used in the lab.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who came to the emergency room, primary care and nephrology unit.
排除标准
- •Subject cannot collect urine in receptacle.
- •Urinary Catheter
结局指标
主要结局
Accuracy to compared device
时间窗: Through study completion, an average of 1 month
The primary objective of the study is to evaluate the accuracy of the S-There device compared to the Lab gold standards, for each analyte.
次要结局
未报告次要终点
研究者
研究点 (2)
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