Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Rhaeos, Inc.
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Flowsense Sensitivity
研究概览
简要总结
This study evaluates the performance of a thermal anisotropy measurement device for non-invasively assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision surgery will be evaluated with the study device to assess flow in CSF shunts as confirmed by surgical outcomes at 7 days. If successful, this study will show that the study device accurately distinguishes between functioning (flowing) and non-functioning (non-flowing) shunts.
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
- •Existing ventriculoperitoneal CSF shunt on which the subject is dependent
- •At least one symptom of shunt malfunction as determined by the investigator, such as but not limited to seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function
- •Exhibit shunt malfunction symptom(s) requiring surgical shunt revision per standard of care assessment without use of device data
- •Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
- •Available for follow-up for up to seven days
- •Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol)
排除标准
- •Presence of more than one distal shunt catheter in the study device measurement region
- •Presence of an interfering open wound or edema in the study device measurement area
- •Subject-reported history of adverse skin reactions to adhesives
- •Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
- •Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
- •Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
- •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
Flowsense Sensitivity
时间窗: Upto 7 days
The study device will yield an output of either "flow confirmed" or "flow not confirmed." Based on this assessment and the standard-of-care clinical treatment, each subject will fall into one of the following categories: True Positive (TP): Device outputs "flow not confirmed" AND a shunt revision surgery with confirmed shunt failure is performed False Positive (FP): Device outputs "flow not confirmed" AND either no shunt revision surgery is performed for 7 days or a shunt revision surgery without a confirmed shunt failure is performed True Negative (TN): Device outputs "flow confirmed" AND either no shunt revision surgery is performed for 7 days or a shunt revision surgery without a confirmed shunt failure is performed False Negative (FN): Device outputs "flow confirmed" AND a shunt revision surgery with confirmed shunt failure is performed Study device sensitivity will be calculated as TP / (TP + FN).
次要结局
- Study device specificity, diagnostic accuracy, positive predictive value (PPV), negative predictive value (NPV), and diagnostic performance(Up to 7 days)