NCT05651867已完成不适用
Prospective Clinical Investigation on the Evaluation of Performance and Safety of the EPIONE Assisted CT-guided Percutaneous Procedures in the Lungs
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Feasibility of the Device
研究概览
简要总结
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.
详细描述
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)
- to evaluate the safety of the device
25 subjectsare planned and will undergo an intervention, during which the clinician will use the EPIONE device
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 ≥18 years old,
- •Patient for whom a percutaneous CT-guided intervention in lung has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
- •Patient with a signed informed consent form.
- •Patient covered by a social security system.
排除标准
- •Patient unable to undergo general anesthesia,
- •Pregnant or nursing female, confirmed before the intervention
- •Patient already participating in another clinical study
结局指标
主要结局
Feasibility of the Device
时间窗: an average of 7 months
Number of lesion target reached ; the lesion target is considered reached when the needle is positioned accurately enough as compared to the planning to allow the planned procedure to be performed.
次要结局
- Needle Placement Accuracy(an average of 7 months)
- Number of Needle Adjustments(an average of 7 months)
- Post-intervention Ablation Success(an average of 1 year)
- Long-term Efficacy of Ablation(through study completion, an average of 1 year)
- Adverse Event(through study completion, an average of 21 months)
- Grade of Needle Adjustment(an average of 7 months)
研究者
研究点 (2)
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