NCT02132975已完成不适用
Pilot Study of a Motorised Probe Holder Assisting Prostate Biopsies
AdministrateurCIC2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年5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
- 20
- 试验地点
- 2
- 主要终点
- Distance between virtual and effective biopsy, in the two arms
研究概览
简要总结
Study, for the first time in clinical conditions, the potential contribution, in terms of accuracy, of the motorised probe holder during prostate biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •of-age patient
- •patient for whom a prostate biopsies session is planned
- •patient affiliated to the social security or equivalent
- •patient having a target identified on MRI
- •Written informed consent
排除标准
- •contraindication
- •patient wearing a mechatronic device
- •patient concerned by the L1121-6 à 8 of the health public code
结局指标
主要结局
Distance between virtual and effective biopsy, in the two arms
时间窗: 8 months
次要结局
- User satisfaction(2 hours)
- Success rate in locking/releasing the probe combined with success rate in performing a full exploration of the prostate(8 months)
- Probe holder positions error between virtual and effective biopsy(8 months)
- Safety Evaluation(2 hours)
研究者
AdministrateurCIC
Coordinating investigator
University Hospital, Grenoble
研究点 (2)
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