Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device, Phase B
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Rhaeos, Inc.
- 入组人数
- 141
- 试验地点
- 9
- 主要终点
- Study Device Sensitivity
研究概览
简要总结
This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.
详细描述
Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. Assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. Standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. This trial will evaluate the ability of the study device to identify shunt malfunctions.
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 Sensitivity
时间窗: 7-day follow-up period
Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.
Study Device Specificity
时间窗: 7-day follow-up period
Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.
次要结局
未报告次要终点
