In Vitro Analysis of Human Urine With the CloudCath Device
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- CloudCath
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Spectral characteristics of urine specimens
研究概览
简要总结
This is a multi-center feasibility study to assess the in vitro function of the CloudCath Device that is being developed to derive clinically-relevant information from the optical characteristics of urine.
详细描述
Specimens will be obtained from participants with indwelling catheters in hospital or home settings, who are suspected to be at high risk for urinary tract infection.
To evaluate the performance of the CloudCath Device in repeated measurements over time, multiple specimens may be obtained from the same patients over multiple days or months.
Each sample will be divided into multiple aliquots. One part will be analyzed using the CloudCath Device and reference devices. Another part may be submitted to an independent lab for standard analytical tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •provide a signed informed consent
- •patient has an implanted urinary catheter (i.e., Foley, Texas, ureteral)
排除标准
- •any condition that the investigator feels may confound the study results or place the participant at risk by participating in the study
- •currently taking antibiotics for any reason other than for treatment of urinary tract infection (UTI)
- •suprapubic bladder catheter implanted
结局指标
主要结局
Spectral characteristics of urine specimens
时间窗: During the period of time that the patient is catheterized (expected to be up to ~1 week)
A quantitative analysis of the spectral properties of the urine specimen using a proprietary algorithm that results in a quantitative CloudCath Turbidity Score (0-100, with higher values indicating more turbidity).
次要结局
未报告次要终点