NCT06524492已完成不适用
Measurements of Flow in Functional Cerebrospinal Fluid Shunts and Off-Shunt Locations with a Second-Generation Wireless Thermal Anisotropy Measurement Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Rhaeos, Inc.
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Study Device Specificity
研究概览
简要总结
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Study Device Specificity
时间窗: Approximately 1 hour
Study device specificity will be calculated as TN / (TN + FP)
Study Device Sensitivity
时间窗: Approximately 1 hour
Study device sensitivity will be calculated as TP / (TP + FN).
次要结局
未报告次要终点
研究者
研究点 (3)
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