NCT06506045终止不适用
Measurements of Flow in Functional and Non-Functional Cerebrospinal Fluid Shunts With a Second-Generation Wireless Thermal Anisotropy Measurement Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Rhaeos, Inc.
- 入组人数
- 10
- 试验地点
- 7
- 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 known non-functional and functional implanted shunts 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
- •At least one existing ventricular CSF shunt, functional or non-functional (including an adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheter disconnection or fracture, distal catheter fragment left in place during shunt surgery, or indication that the shunt is otherwise non-functional), with a region of overlying intact skin appropriate in size for application of the study device
- •If more than one distal shunt catheter is present, at least one distal shunt catheter is at least 2 cm away from any other distal shunt catheter in the device measurement region
- •Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- •Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- •Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision
排除标准
- •Presence of an interfering open wound or edema in the FlowSense device measurement area
- •Patient-reported history of adverse skin reactions to adhesives
- •Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
- •New or worsening symptoms of a possible shunt malfunction in the prior 7 days
- •Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
- •Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
结局指标
主要结局
Study Device Specificity
时间窗: Up to 1 hour
Study device specificity will be calculated as TN / (TN + FP)
Study Device Sensitivity
时间窗: Up to 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 (7)
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