NCT02563444已完成不适用
Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology
University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Measure of the averages (m) errors of the coordinates in the three planes of space, between the virtual and the real line of the spinal needle (comparison of ultrasound fusion data with control CT scan data achieved once the spinal needle is placed)
研究概览
简要总结
The investigators want to evaluate the accuracy of an ultrasound fusion guiding system in the positioning of a needle (here the accuracy is evaluated with a 22G spinal needle), by comparing the path indicated by the ultrasound fusion (virtual line) and the path actually obtained on the control CT scan (real line).
Compared with ultrasound guidance alone or CT scan alone, the results are expected to be more accurate, saving time and irradiation (not evaluated here).
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 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age>18 years
- •male or female
- •women of childbearing potential should use effective contraceptive measures and indicate the date of the last menstrual
- •Patient requiring the use of computed tomographic guidance to perform a diagnostic (biopsy) or therapeutic procedure (infiltration, ablation) on a mobile organ
- •patient signed an informed consent
排除标准
- •Contraindications to the use of X-rays (pregnancy)
- •Patients using vital electronic devices (eg: pacemaker or defibrillator)
- •Subject under judicial protection
- •Subject under tutorship or curatorship
- •Inability to give informed informations (subject in emergency situations, comprehension difficulties of the subject, ...)
结局指标
主要结局
Measure of the averages (m) errors of the coordinates in the three planes of space, between the virtual and the real line of the spinal needle (comparison of ultrasound fusion data with control CT scan data achieved once the spinal needle is placed)
时间窗: time of the procedure
次要结局
- overall satisfaction score(time of the procedure)
- distance between the center of the target and the extension of the spinal needle (perpendicular line to this projection through the center of the lesion)(time of the procedure)
研究者
研究点 (2)
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