Wireless HOME Monitoring of Intracranial (BRAIN) PRESSURE
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 3 months post-surgery
研究概览
简要总结
Patients with hydrocephalus have an abnormal build-up of fluid around the brain and need a tube surgically implanted to drain that fluid. Patients and their caregivers live with the constant fear that the tube will block. Warning symptoms include irritability, headaches and vomiting. Unfortunately, there is no way of telling when fluid build-up is causing a rise in brain pressure and potentially impeding blood flow to the brain (life threatening) except for a brain scan in hospital and possibly hospitalisation.
The investigators want to improve the lives of patients with hydrocephalus. They have developed a tool for parents and caregivers to monitor the pressure in the brain remotely via a sensor placed alongside the drainage tube. The device has been shown to be safe and to give reliable brain pressure readings using a large animal model (sheep). This study is a first-in-human safety study to show it is safe for patient use.
详细描述
Participants with hydrocephalus who are at risk of repeated bouts of hospitalisation associated with shunt failures and therefore likely to benefit from being able to monitor intracranial pressure will be recruited. 10 adult (>16 years) and 10 children (1-15 years) participants will be recruited in a staggered fashion to allow appropriate evaluation of outcomes. Participants will be recruited when they present to hospital requiring a shunt placement (or revision). At the same time as this surgery, the Kitea Sensor will be placed in the brain near the shunt. Participants will be asked to make measurements of their brain pressure at home using the Kitea ICP System for the next 3 months. Aside from the placement of the Kitea Sensor and home measurements of ICP using the Kitea ICP system, all clinical interventions will be standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a condition requiring cerebral spinal fluid shunting who are undergoing initial shunt placement or shunt revision surgery.
- •Adults: Age > 16 years; Children: Age >1 and <15
排除标准
- •Adults: Unable to give informed consent
- •Paediatric: Failure to obtain assent in a cognitively competent child along with parental consent or parent unable to consent.
- •Cortical mantle < 20 mm
- •Neurologic or other condition that would prevent compliance with protocol
- •Terminal illness with expected survival < 1 year
- •Unable to participate in follow-up for 3 months (e.g., travelling overseas for an extended period)
- •Underlying medical condition that would make the participant more prone to surgical infections
- •Other active implanted medical devices e.g. pacemaker, cochlear implant, implantable cardioverter defibrillator, deep brain stimulation devices
- •Participants with conditions likely to require radiation therapy
研究组 & 干预措施
Kitea ICP Sensor
At the same time as this surgery, the Kitea Sensor will be placed in the brain near the shunt. Participants will be asked to make measurements of their brain pressure at home using the Kitea ICP System for the next 3 months. Aside from the placement of the Kitea Sensor and home measurements of ICP using the Kitea ICP system, all clinical interventions will be standard of care.
干预措施: Kitea ICP Sensor (Device)
结局指标
主要结局
Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 3 months post-surgery
时间窗: 3 months
The primary end point for this study is the proportion of recruited participants who have no safety or tolerability issues in the 3 months post-surgery as assessed by a lack of serious adverse events attributable to the Kitea ICP System or participants requesting device removal.
次要结局
- Recruitment rate(Through study completion, an average of 1 year)
- Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 6 months post-surgery(6 months)
- Data completeness of home ICP recordings using the Kitea ICP system.(3 months)
- Participant satisfaction with the requested frequency of making ICP recordings using the Kitea ICP System.(3 months)
研究者
Sarah-Jane Guild
Principal Investigator
University of Auckland, New Zealand