NCT00828893已完成2 期
Interest of the Use of a Navigation Guidance Gestures Carried Out Under CT
AdministrateurCIC1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia.
研究概览
简要总结
The purpose of this study is to assess the contribution of navigation systems recently developed to guide the punction needle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •more or equal than 18 years old
- •patient affiliated to social security or similarly regime
- •patient sent to hospital for drain under CT
排除标准
- •Pregnant women and lactating mothers
- •Ward of court or under guardianship
- •Adult unable to express their consent
- •Person deprived of freedom by judicial or administrative decision
- •Person hospitalized without their consent
- •Person under legal protection
- •Person participating in another clinical study
结局指标
主要结局
Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia.
时间窗: 2 hours
次要结局
- Maximum distance between the planned trajectory and trajectory achieved by the needle puncture.(2 hours)
- Duration of intervention(3 hours)
- Dose irradiation and number of control scanners made(3 hours)
- overall satisfaction Score(3 hours)
- Success or failure of the final gesture made(3 hours)
- Number of attempts(3 hours)
- number of complications (per-operative, post-surgery)(7 days)
研究者
AdministrateurCIC
principal investigator
University Hospital, Grenoble
研究点 (1)
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