A Study for Monitoring Subjects With Fluid-Management Issues Using Repeated Measurements In the Home Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Ease of Use
研究概览
简要总结
This study is designed to validate ease-of-use for the CoVa Monitoring System, along with simple statistical parameters such as reproducibility and inter-subject agreement between test and reference devices.
详细描述
The study has the following objectives:
Objective 1: investigate ease-of-use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational
Objective 2: determine if daily application of the Sensor's adhesive Electrodes resulted in any skin irritation
Objective 3: determine that the long-term reproducibility of measurements made by the test device is as good or better than the long-term reproducibility of the reference device
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening.
- •Subject will have a current prescription for a diuretic medication.
- •Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
- •Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.
排除标准
- •Subject is participating in another clinical study that may affect the results of either study.
- •Subject is unable or not willing to wear electrode patches as required.
- •Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
- •Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
- •Subject is considered by the PI to be medically unsuitable for study participation.
结局指标
主要结局
Ease of Use
时间窗: Each subject will be measured once per weekday over a 6 week period
Investigate ease of use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational
次要结局
- SKin irritation and reproducibility(Each subject will be measured once per weekday over a 6 week period)