A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
The Velieve U.S. UTI Urine Analysis Test System (henceforth Velieve U.S.) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance,including providing a urine sample and scanning the urine strip after placing it on the Color-Board. The user will also complete a questionnaire to collect information regarding the use of the Velieve U.S. device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device.
The use of the Velieve U.S. device will be evaluated for identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Florida
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West Palm Beach、Florida、美国、33409
- Comprehensive Clinical Trials, LLC
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Males and Females 18-80 years of age;
- Subjects who are healthy or:
Subjects with a medical condition that normally present with an abnormal concentration of Leukocytes, Nitrites and Blood: (examples of such conditions include the following):
- Urinary tract infection (UTI)
- Patients with suspected or known occult blood in urine
- Pregnant women
- 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.
- Subject is familiar with the use of a smartphone
- Subject is capable of comprehending and following instructions in English
Exclusion Criteria:
- Subject has dementia.
- Subject has mental disorders.
- Subject cannot collect urine in a receptacle.
- Subject is visually impaired (cannot read the user manual).
- Any additional reason the study physician believes disqualifies the subject from participating in the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Velieve U.S.
Each participant will test their urine sample using the Velieve U.S. device
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The Velieve U.S. is a home use, in-vitro diagnostic (IVD) device.
The device is used for the semi-quantitative detection of blood and leukocytes, and the qualitative detection of nitrites in urine.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Evaluation of the % agreement of the Velieve U.S., tested by the lay user, as compared to a comparator device, tested by a professional user.
大体时间:11 months
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11 months
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次要结果测量
结果测量 |
大体时间 |
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Evaluation of the Velieve U.S. usability success rate, by potential lay users under actual use conditions.
大体时间:11 months
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11 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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