Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of ICP values obtained by the HS device that correlate to ICP using current standards
研究概览
简要总结
Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal pressure transducer or external ventricular drain (EVD), provides an ICP waveform that encapsulates valuable diagnostic and monitoring clinical information.
HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to display an ICP waveform safely and accurately with minimal discomfort to patients, compared to standard invasive ICP monitoring procedures used at the participating institutions.
详细描述
A study will be conducted on 100 patients who undergo invasive ICP measurement due to suspected ICP elevation, regardless to etiology. Each enrolled patient will be monitored with the HS-1000 device and data will be collected throughout the entire procedure. Once the data collection is done, results of the non-invasive measurements will be analyzed accordingly. The end-point of the study is to collect at least half an hour of measurements for each participant.
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
- •Adult men and women subjects, aged 18 years old and over at screening visit
- •Subjects with neuropathology that the principal investigator considers including in this study.
- •Survival expectancy greater than 72 hours
- •Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
- •Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study
排除标准
- •Local ear infection
- •Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
- •For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding
- •Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
- •Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition)
结局指标
主要结局
Number of ICP values obtained by the HS device that correlate to ICP using current standards
时间窗: 30 minutes
次要结局
未报告次要终点