NCT07217041已完成不适用
A Pilot Clinical Study to Assess the Correlation Between Fluid Removal During Dialysis and HemoCept Device Data
HemoCept Inc.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年3月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Correlation between HemoCept device and changes in dry weight.
研究概览
简要总结
The goal of this clinical pilot study is to evaluate the ability of the device to properly detect the hydration status of the subject through the study of fluid removal data during dialysis and HemoCept device data.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study or representatives must have voluntarily signed the informed consent form before any study related procedures
- •Subjects can be any gender, but must be between (and including) 18 and 75 years of age
- •Subject has been on dialysis for more than 90 days and has been diagnosed with end stage kidney disease
- •Subject is willing and able to provide informed consent and HIPAA authorization • Subject is able and willing to meet all study requirements
- •Subject is able to place electrodes on bilateral deltoids and above the pant line on the waist
排除标准
- •Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
- •Subject has a personal medical history that includes:
- •Long Q-T syndrome
- •Cardiac channelopathies, genetic heart defects
- •Acute untreated blood clotting disorders or acute untreated bleeding disorders
- •Subject has had a heart transplant.
结局指标
主要结局
Correlation between HemoCept device and changes in dry weight.
时间窗: At specified points during dialysis treatment for 9 dialysis sessions, over the course of 3 weeks.
The primary end point will be to determine if there is a correlation between HemoCept device data and dry weight changes during dialysis. The primary analysis will be conducted at specific points during dialysis treatment: prior to dialysis, in the middle of the dialysis session, and immediately following the completion of dialysis treatment.
次要结局
- Device-related adverse events: device-related adverse events included all adverse events classified as definitely, probably, possibly, or undetermined relation to the device or procedure(From enrollment until the completion of 9 dialysis sessions, over a period of 3 weeks.)
研究者
研究点 (1)
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