Post-Market Clinical Follow-Up Study of a Robotic Device for Image Guided Percutaneous Needle Placement in the Abdomen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Technical Success
研究概览
简要总结
Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen
详细描述
The objective of this PMCF study is to compile data on the routine use of the EPIONE® device in subjects undergoing CT-guided percutaneous procedures in the abdomen.
The objectives are:
- to evaluate the technical success of the device
- to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence, operator satisfaction) and the safety of the device
55 patients are planned in this post-market study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 >18 years old,
- •Patient for whom a CT-guided procedure in abdomen has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
- •Patient with a confirmed non-opposition.
排除标准
- •Patient unable to undergo general anesthesia,
- •Pregnant or breast-feeding females
研究组 & 干预措施
Intervention with the EPIONE® device
Patients treated by percutaneous CT-guided procedures in the abdomen with the EPIONE® device
干预措施: EPIONE® CT-Guided Percutaneous procedures (Device)
结局指标
主要结局
Technical Success
时间窗: Visit 2 - D0 The day of the intervention
Number of targets reached ; the target is considered to have been reached when the needle is positioned accurately enough to allow the planned procedure to be performed (by patient)
次要结局
- Number and Nature of Needle Adjustments to Reach the Target(Visit 2 - D0 The day of the intervention)
- Needle Placement Accuracy(Visit 2 - D0 The day of the intervention)
- Operator Satisfaction(Visit 2 - D0 The day of the intervention)
- Post-intervention Ablation Success(Until Visit 4 - Routine FU visit at 10 months)
- Local Tumor Recurrence(Until Visit 4 - Routine FU visit at 10 months)
- Adverse Events Related to Device or Procedure(Until Visit 4 - Routine FU visit at 10 months)
- Device Dysfunction(Visit 2 - D0 The day of the intervention)