NCT02573545终止不适用
Evaluation of a Support Software in the Planning and Real-time Monitoring of the Insertion of Needles in Interventional Magnetic Resonance Imaging (MRI): Liver Biopsy Case
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2013年1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
- 终止
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Total duration of the intervention (planning and implementation)
研究概览
简要总结
To demonstrate that the use of Standard @IFE and Planning@IFE features of the IFE software, compared to the current method, when planning and inserting the needle under MRI monitoring in the context of liver biopsies enable:
- a facilitation of the planning stages of the procedure (route path, marking of the entry point and alignment of the MRI cutaways on the planned path), resulting in a reduction in the duration of the planning stages,
- a facilitation of the real-time modification of MRI cutaways during the procedure, resulting in a reduction of the duration of the procedure
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
- •Patient is at least 18 years old
- •Affiliated to a social security scheme
- •Informed consent
- •Patient with an indication of liver biopsy eligible for a biopsy under interventional MRI
排除标准
- •Patient with a contraindication for MRI exam
- •Patient with a contraindication for performing a biopsy
- •Pregnancy
- •Exclusion period
- •Patient unable to receive and understand information about the study
- •Patients under guardianship
- •Patients under judicial protection
研究组 & 干预措施
Test group: with IFE
Experimental
Patients treated with IFE software
干预措施: Planning@IFE and Standard@IFE Software (Device)
Test group: without IFE
Active Comparator
Patients treated with Numaris 4 software
干预措施: MR Syngo (Numaris/4) software (Device)
结局指标
主要结局
Total duration of the intervention (planning and implementation)
时间窗: up to 2 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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