Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Number of true/false positive and true/false negative detections of cerebrospinal fluid marked in case report form
研究概览
简要总结
This is clinical feasibility study on the device performance with paediatric patients. The main objective is to validate the performance of investigational device in distinguishing and identifying the cerebrospinal fluid (CSF) inside the subarachnoid space during a lumbar puncture on paediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children whose diagnosis or treatment plan requires lumbar puncture to acquire a CSF sample.
- •Consent from the parents
排除标准
- •Being a high risk patient (as determined by the investigator)
- •Any contraindication to a common lumbar puncture apply also in the investigation
研究组 & 干预措施
Injeq IQ-Needle
Lumbar puncture is performed using Injeq IQ-Needle
干预措施: Injeq IQ-Needle (Device)
结局指标
主要结局
Number of true/false positive and true/false negative detections of cerebrospinal fluid marked in case report form
时间窗: During lumbar puncture
Measurement device indicates with a sound and visual feedback when needle reaches cerebrospinal fluid (CSF). Physician verifies the location by removing the needle stylet and testing whether CSF flows from the needle, similarly as in traditional process. Detection is true positive if CSF flows from the needle and false positive if not. Even if the device does not detect CSF, physician performs the CSF test when needed. Physician marks to the case report form whether the device provided detections during the lumbar puncture and were the detections true or false detections.
次要结局
未报告次要终点