NCT07317648已完成不适用
ClearSight NextGen System Clinical Development Study
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Data Collection for Development of ClearSight NextGen System
研究概览
简要总结
A prospective, non-randomized single arm study using the investigational ClearSight NextGen (CSNG) system in adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Signed informed consent
- •Age ≥ 18 years
- •Planned or existing monitoring with an arterial catheter as part of standard of care
- •Patient scheduled to undergo surgery with general anesthesia lasting > 2 hours
排除标准
- •Any significant disfigurement or prior injury to a participant's finger that is intended to be used for monitoring with the study finger cuffs
- •Known left-right difference in blood pressure
- •Extreme contraction of the smooth muscles in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease
- •Patients deemed not suitable for the study at the discretion of the Investigator
- •Participation in another study that clinically interferes with the current study
- •Treatment with an intra-aortic balloon pump
- •Cardiac surgery including bypass period
研究组 & 干预措施
Adult OR patients with planned or existing arterial blood pressure monitoring
Experimental
干预措施: ClearSight NextGen system (Device)
结局指标
主要结局
Data Collection for Development of ClearSight NextGen System
时间窗: Monitoring during surgery, for up to approximately 4 hours.
The objective of the study is to collect systolic and diastolic blood pressure data using the investigational CSNG system alongside CE-Marked ClearSight and FloTrac devices in adult subjects.
次要结局
未报告次要终点
研究者
研究点 (2)
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