Non-Invasive Monitoring of End-Stage Renal Disease Subjects Using Alio Medical Remote Monitoring System (RMS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Alio, Inc.
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- 1.Alio Device comparison to K+ via blood draw
研究概览
简要总结
To compare the Alio device to blood draws.
详细描述
Eligible subjects who have signed a consent form will be asked to wear the Alio device at specified location(s) for up to four regularly scheduled dialysis sessions. The device will be placed and worn throughout the entire session.
Subjects will have blood draws that will be used to compare to device metrics. Additional vitals and monitoring may happen throughout this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •18 and older
- •maintenance dialysis for ESRD via AVF/AVG in an arm location for at least 6 months
- •written informed consent
- •able to wear the SmartPatch as instructed and follow study protocols
排除标准
- •Skin near the proximity of Patch placement is swollen, infected and/or inflamed
- •pregnancy
- •serious medical condition which in the opinion of the investigator may adversely affect the safety of the subject or the device being evaluated
- •AVF/AVG in a non-arm location
- •participants with novel indications for their AVG (ie. HeRO grafts)
- •participation in any other clinical trials that could affect the quality of study data
结局指标
主要结局
1.Alio Device comparison to K+ via blood draw
时间窗: through study completion, an average of 1 year
Compare the Alio device to dialysis clinic blood lab values drawn before and after dialysis. The Potassium value collected will be compared to the Alio device.
1.Alio Device comparison to Hct via blood draw
时间窗: through study completion, an average of 1 year
Compare the Alio device to dialysis clinic blood lab values drawn before and after dialysis. The Hematrocrit (%) value collected will be compared to the Alio device.
次要结局
未报告次要终点