Comparison of a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method (PunctureCube)
Prospective, Randomized, Controlled, Parallel Group Study to Compare a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method
研究概览
详细说明
Computed tomography (CT)-guided interventions for diagnostic and therapeutic purposes are standard approaches in clinical routine (e.g. in patients with low back pain). Numerous CT needle navigation systems have been developed with the aim to improve accuracy (and thus safety) of punctures while decreasing radiation exposure and procedure time. Their usability in clinical routine is limited either because of high sensitivity to interference, high expenses, bulkiness, or incompatibly with daily clinical practice and thus increasing procedure time and workflow complexity. The Puncture Cube® takes into account all these requirements. Furthermore, in an in vitro-phantom study (study submitted for publication), punctures with the Cube were found to be faster and more accurate compared to the free-hand conventional method.
In a prospective, randomized, controlled, parallel group study the accuracy, intervention time and radiation dose of CT-guided punctures using the Puncture Cube® will be compared to the conventional free-hand method in patients requiring a percutaneous diagnostic or therapeutic CT-guided intervention for lumbar pain (facet joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level).
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Luca Remonda, Prof.
- 电话号码:+41 62 838 43 21
- 邮箱:luca.remonda@ksa.ch
学习地点
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Aargau
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Aarau、Aargau、瑞士、5001
- 招聘中
- Department of Neuroradiology, Kantonsspital Aarau
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接触:
- Luca Remonda, Prof.
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients requiring a percutaneous therapeutic CT-guided intervention for
- lumbar pain (joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level)
- age ≥ 18 years
- Signed informed consent prior to intervention
Exclusion Criteria:
- Patients suffering from severe obesity (BMI > 30 kg/m2)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:Free-hand lumbar punction
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the free-hand method.
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Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
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有源比较器:Puncture Cube
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
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Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Puncture accuracy
大体时间:during procedure time approximately 30 min.
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Assessment of puncture accuracy (distance and angle error between planned and achieved trajectory)
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during procedure time approximately 30 min.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of control acquisitions to achieve target
大体时间:during procedure time approximately 30 min.
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Number of control acquisitions to achieve target
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during procedure time approximately 30 min.
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Assessment of radiation dose
大体时间:during procedure time approximately 30 min.
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Assessment of radiation dose
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during procedure time approximately 30 min.
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Assessment of intervention time
大体时间:during procedure time approximately 30 min.
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Assessment of intervention time
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during procedure time approximately 30 min.
|
合作者和调查者
赞助
调查人员
- 首席研究员:Luca Remonda, Prof.、Department of Neuroradiology, Kantonsspital Aarau
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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