The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- The First Puncture Success Rate
研究概览
简要总结
The investigation aims to demonstrate the first puncture success rate, as proxy of clinical benefit and clinical performance, of bioimpedance spectroscopy based spinal needle guidance method among pediatric hemato-oncology patients requiring lumbar punctures.
详细描述
The primary purpose of the investigation is to demonstrate the claimed clinical benefit and safety of Injeq IQ-Tip™ system.
IQ-Tip™ is similar to common spinal needles with a custom-made stylet that enables the real-time bioimpedance measurement at the tip of the needle. The needle is connected to the analyzer device, which provides real-time CSF detection during lumbar puncture from the very tip of the needle and by these means assists conducting the medical procedure.
The investigation aims to demonstrate the first puncture success rate, as proxy of clinical benefit and clinical performance, of bioimpedance spectroscopy based spinal needle guidance method among pediatric hemato-oncology patients requiring lumbar punctures.
The investigation is conducted in the pediatric hematology and oncology units of three Finnish university hospitals
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
- 18 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric hemato-oncology patients whose diagnosis or treatment plan requires lumbar puncture to acquire a CSF sample or to inject drug or other substance
- •Written and signed informed consent before the procedure from the parent and/or patient depending on the age of the patient
排除标准
- •Parents and/or patient refusal to participate or parents and/or patient unable to give informed consent
- •Any contraindications to a lumbar puncture. Contraindications include skin infection around the puncture area, unstable hemodynamics, bleeding tendency and increased intracranial pressure
结局指标
主要结局
The First Puncture Success Rate
时间窗: The assessment immediately following each lumbar puncture procedure
Each individual lumbar puncture procedure is assessed as either 'first puncture success' or '-failure'. Success rate = Successes / All procedures Definition of the first puncture success: * Only one skin puncture with the needle is allowed; * Multiple stylet removals and reinsertions are allowed; * Multiple needle reorientations are allowed as long as needle tip remains inside the skin; * Physician must be able obtain a cerebrospinal fluid (CSF) sample that is sent to a laboratory analysis or to inject the intended medication to the patient's subarachnoid space; and * Physician conducting the puncture remains the same during the procedure
Rate of Serious Adverse Events
时间窗: The assessment during four-week follow-up after each lumbar puncture procedure
Total number of serious adverse events caused by the device. Serious adverse event in probable or causal relationship to the investigational device exposure
次要结局
- Percentage of Procedures With Post-dural Puncture Headache (PDPH)(The assessment during 7-day follow-up after each lumbar puncture procedure)
- Percentage of CSF Samples With Greater or Equal to 10 Erythrocytes / mm^3(The laboratory analysis within 3 hours of the lumbar puncture)
- Percentage of Procedures With Other Complications or Adverse Events(The assessment during 7-day and four-week follow ups)
- Aggregate Sensitivity of CSF Detection(The assessment immediately following each lumbar puncture procedure)
- Aggregate False Detection Rate of CSF Detection(The assessment immediately following each lumbar puncture procedure)
- Number of Required Attempts Per Successful Lumbar Puncture Procedure(The assessment immediately following each lumbar puncture procedure)
- Number of Failed Lumbar Puncture Procedures(The assessment immediately following each lumbar puncture procedure)