Long-Term Tracking of Fluid Dynamics in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device During Activities of Daily Living Including Sleep
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Rhaeos, Inc.
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Adverse Device Effects
研究概览
简要总结
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during activities of daily living and sleep
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Existing ventricular CSF shunt
- •(Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure
- •(Cohort B) A shunt revision in the previous 7 days and the investigator judges that the patient will likely be discharged within 4 days of the enrollment date
- •Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
- •Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- •Subject is at least 5 years old but < 22 years old
排除标准
- •Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
- •Presence of an interfering open wound or edema in the study device measurement region
- •Subject-reported history of serious adverse skin reactions to silicone-based adhesives
- •Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
- •Investigator judges that the subject is unlikely to successfully take reliable measurements at home
- •Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
- •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
- •Prior enrollment in this study
- •Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
研究组 & 干预措施
No Recent Revision
Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure will be enrolled.
干预措施: wireless thermal anisotropy measurement device (Device)
Recent Revision
Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a shunt revision in the previous 7 days who the investigator judges will likely be discharged within 4 days of the enrollment date will be enrolled.
干预措施: wireless thermal anisotropy measurement device (Device)
结局指标
主要结局
Adverse Device Effects
时间窗: 30 days
The co-primary endpoints in this study are the rate of ADEs and SADEs that occur per wear hour.
次要结局
- Usability score(30 days)
- ADEs and SADEs per wear period(30 days)
- ADEs and SADEs per subject(30 days)
- Device deficiencies resulting in incomplete monitoring data(30 days)
- Local skin reactions per wear session;(30 days)
- ADEs and SADEs that preclude the continued use of the study device(30 days)