Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Rhaeos, Inc.
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Study device negative predictive value (NPV)
研究概览
简要总结
This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predictive value (NPV; Part 1, blinded) and explore changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits (Part 2, unblinded).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Existing ventricular cerebrospinal fluid shunt
- •Age ≥ 2 years old
- •Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device
- •Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent
- •Standard of care outpatient visit with neurosurgeon assessment of having "no clinical concern for shunt malfunction"
排除标准
- •Subject not scheduled to receive outpatient standard of care imaging (CT, MRI, X-ray shunt series) as part of the clinic visit
- •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 region
- •Subject-reported history of adverse skin reactions to silicone adhesives
- •Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject
- •Subject not available for seven-day follow-up
研究组 & 干预措施
Observational, part 1 (blinded)
干预措施: Thermal Anisotropy Measurement Device (Device)
Diagnostic, part 2 (unblinded)
干预措施: Thermal Anisotropy Measurement Device (Device)
结局指标
主要结局
Study device negative predictive value (NPV)
时间窗: Up to 7 days
The study device will produce either "flow confirmed" or "flow not confirmed" data in a blinded fashion. Ground truth will be established based on 7-day follow-up an intraoperative observations for any surgery performed per the standard of care.
次要结局
- Study device sensitivity, specificity, diagnostic accuracy, and positive predictive value (PPV)(Up to 7 days)