NCT07217470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 26 人开始时间: 2025年8月18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
- 26
- 试验地点
- 1
- 主要终点
- Correlation between dry weight changes and HemoCept device measurements.
研究概览
简要总结
The pilot clinical study will assess the correlation between fluid removal 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
- •Subject 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 able and willing 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, Seizures, 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 dry weight changes and HemoCept device measurements.
时间窗: Before and after one dialysis session, over the course of 1 day
The primary analysis will be conducted using HemoCept device readings taken before dialysis and at the end of dialysis, just prior to return of blood and fluid from the machine. The device data will then be assessed for its comparison to dry weight changes.
次要结局
- Device related adverse events, and the possible correlation of skin tone to device results.(Before and after 1 dialysis session, over the course of 1 day.)
研究者
研究点 (1)
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