Clinical Evaluation of the CM-1500 During Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Average Relative Index Value Following a Hemodialysis Procedure
研究概览
简要总结
The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 20 subjects consented to undergo a hemodialysis session as a part of their standard prescribed treatment plan. Subjects will consent to undergo non-invasive monitoring with the CM-1500 during three (3) separate sequential hemodialysis sessions.
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
- •Ability to provide written informed consent
- •Ability and willingness to comply with the study procedures and duration requirements, including connection of the device to the left wrist/hand and maintaining relatively motionless during the session
- •18 years of age or older
- •Planned to undergo a minimum of three (3) hemodialysis sessions within the two (2) weeks following enrollment.
排除标准
- •Females who are pregnant or breastfeeding
- •Undergone an amputation of the left upper extremity
- •Subjects with left arm hemodialysis access only
- •Diagnosed with dextrocardia
- •Subjects who have a pacemaker
- •Subjects who have any other underlying condition that would inhibit completion of participation in the study, per Investigator opinion
结局指标
主要结局
Average Relative Index Value Following a Hemodialysis Procedure
时间窗: Duration of post-hemodialysis recovery period (10-minutes)
The primary objective is to characterize the average CM-1500 Relative Index (RI) following a hemodialysis procedure. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline. The average RI after dialysis procedure was calculated by averaging all measured RI values for all subject sessions (3 sessions per subject, totaling 45 sessions) during the 10-min post-hemodialysis recovery period.
次要结局
- Mean Intersubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions(Duration of standard dialysis procedure (Range: 131 to 241 minutes))
- Mean Intrasubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions(Duration of standard dialysis procedure (Range: 131 to 241 minutes))