A Prospective Clinical Study to Assess the Clinical Utility of Turbidity With the CloudCath System in Patients Using In-Home Peritoneal Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CloudCath
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Time to peritonitis diagnosis
研究概览
简要总结
This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.
详细描述
This study will evaluate the safety and effectiveness of the CloudCath System to detect the onset of peritonitis as compared to standard of care.
Study Participants will connect the CloudCath System to their home peritoneal dialysis unit and the CloudCath System will analyze the effluent dialysis solution for changes associated with peritonitis. The system will alert the participant and healthcare provider if it detects a possible infection so they can be formally diagnosed by their healthcare provider.
Following enrollment, Study Participants will use the CloudCath System for 12 continuous months.
Study results from the ACT study will be compared to the results of the CATCH Study (Protocol number CC-P-001; NCT04515498). In CATCH, the Study Participants used a CloudCath System; however, the notification capabilities (per the CloudCath System algorithm) were deactivated.
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
- 否
入选标准
- •currently using peritoneal dialysis
- •provides informed consent
- •willing to comply with the requirements of the study
- •has cellular data coverage at home
排除标准
- •active or history of cancer requiring chemotherapy within prior 6 months
- •signs or symptoms of an active infection within 14 days prior to enrollment
- •peritonitis diagnosis within 30 days prior to enrollment
- •participating in another investigational device or drug study that may potentially affect study results
- •other medical, social or psychological problems that, in the opinion of the investigator, exclude the study participant from the study
结局指标
主要结局
Time to peritonitis diagnosis
时间窗: 12-months
The time between detection by the CloudCath System and laboratory confirmation of peritonitis.
次要结局
- Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event.(12-months)
- Agreement in peritonitis detection between the CloudCath System and clinical criteria.(12-months)
- Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis(12-months)
- Sensitivity and Specificity of the CloudCath System to detect peritonitis as compared to diagnostic laboratory testing(12-months)