NCT02360241已完成不适用
LPRobacus: Light Needle Positioning Robot Under MRI Guidance
University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Amount of needle positioning needed to reach the real path wanted, with a 5mm precision (cylinder diameter including the path defined by the two skin marker and the need axe).
研究概览
简要总结
This study aim is to evaluate the needle positioning precision, compared to the real path planned by the physician on healthy voluntaries, by positioning a fictional needle, without inserting it.
Additionally, this study will evaluate:
- the robot precision,
- the robot detection robustness,
- the software and device ergonomics,
- the device security.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •person over 18 years old,
- •person with height is under 1m90,
- •person with abdomen height is under 28 cm,
- •person with abdomen width is between 26 cm to 50 cm,
- •person able to hold his breath during 30 seconds,
- •person affiliated to social security or similarly regime,
- •signed consent for participation in the study.
排除标准
- •person with a contraindication for abdomen MRI,
- •claustrophobic person,
- •protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
研究组 & 干预措施
Robot
Experimental
A robot will be used and it's position will be evaluated
干预措施: Robot (Device)
结局指标
主要结局
Amount of needle positioning needed to reach the real path wanted, with a 5mm precision (cylinder diameter including the path defined by the two skin marker and the need axe).
时间窗: 1hour20minutes
evaluate the real needle positioning precision: the robot effectiveness
次要结局
- Score from a qualitative evaluation scale of the healthy voluntary discomfort during robot use and the score from a scale of the physician satisfaction (girth, ease, speed).(1hour20minutes)
- Number of time in percentage of failed robot use.(1hour20minutes)
- Number of time in percentage that the robot was stopped (voluntary/dysfonctionnement) during its use(1hour20minutes)
- Number of time in percentage of failed fixation of the robot over the patient.(1hour20minutes)
研究者
研究点 (1)
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