Scanadu Urine Device Validation Study Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Usability: % successful scans in three tests conducted by lay users in following the app on the iPhone and obtain user experience on questionnaire
研究概览
简要总结
This study will test Scanadu Urine Device for clinical performance and usability.
详细描述
The objectives of this study are to:
- Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396).
- Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device.
- Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels
研究设计
- 研究类型
- 干预性
- 分配方式
- 非随机
- 干预模型
- 平行分组
- 主要目的
- 诊断
- 盲法
- 单盲 (受试者)
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
- Female and male
- 18 years old or older
- Pregnant or not pregnant
- Must have experience using an Apple iPhone
- Have no visual impairments
- Able to hold Smart Phone horizontally in raised dominant hand
- Must be able to read and understand English
- Must provide Informed Consent
排除标准
- Has a known history of a visual impairment that may affect reading and navigating the Scanadu Urine app
- Unable to void and collect urine specimen for testing
- Unable to hold phone steady (horizontally) or has history of tremors or conditions such as Parkinson's disease
研究组 & 干预措施
Usability
Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device.
干预措施: Scanadu Urine Device (Device)
Method Comparison
Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to:
- The visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396),
- Scanadu Urine Device tests performed by lab technicians.
干预措施: Scanadu Urine Device (Device)
Reproducibility
Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels.
干预措施: Scanadu Urine Device (Device)
结局指标
主要结局
Usability: % successful scans in three tests conducted by lay users in following the app on the iPhone and obtain user experience on questionnaire
时间窗: Single visit in one day
Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device.
Method Comparison: Conduct two tests by following iPhone app (self and patient samples), results in concordance with professional testers; achieve accuracy in different concentrations of six urine analytes each using approximately 20 samples per level.
时间窗: Single visit in one day
Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396).
Reproducibility: Lay user's ability to repeat a urine test nine times by following iPhone app and obtain nine results that are in concordance.
时间窗: Single visit in one day
Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels
次要结局
未报告次要终点
研究者
研究点 (2)
标识符
- NCT 编号
- NCT02973178
- 其他研究编号
- FO-004
日期
- 首次提交
- (9年前)
- 首次发布
- (9年前)
- 主要完成日期
- (9年前)
- 研究完成日期
- (9年前)
- 最近核实
- (9年前)
- 最近更新
- (9年前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否