Multicenter Study to Evaluate the Safety and Performance of the Quantum Surgical Robotic Device for Image-guided Percutaneous Needle Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Evaluation of the feasibility of the Quantum Surgical device: Number of targets reached
研究概览
简要总结
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
详细描述
The device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of needle, as well as in verification of needle position during CT guided percutaneous ablation procedures.
After validation of the correct positioning of the needle, the tumor ablation procedure is conducted with a device routinely used by the investigator. The Acquisition of a post-interventional CT-guided image is realized to evaluate adverse events occurrence.
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 Months 至 —（Child, 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,
- •Patient for whom an ablation procedure under CT guidance in liver organ has been prescribed and consensually agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
- •Patient not taking platelet antiaggregant or having stopped taking it for 5 days and not taking anticoagulant (thrombocytes ≥ 50 000/mm3, TP > 50%),
- •Patient who agrees to participate in the evaluation and who has signed the inform consent,
- •Patient covered by social security system.
排除标准
- •Patient unable to undergo general anesthesia,
- •Patient unable to tolerate CT contrast agent
- •Patient already participating in another clinical study
- •Pregnant or breast-feeding woman.
研究组 & 干预措施
Robotic device
Needle placement to the tumor, one time, the day of the ablation procedure
干预措施: The Quantum Surgical device (Device)
结局指标
主要结局
Evaluation of the feasibility of the Quantum Surgical device: Number of targets reached
时间窗: During the procedure
Number of targets reached; the target is considered to have been reached when the needle is positioned accurately enough to allow the next step of the procedure to be carried out
Evaluation of the safety related to the procedure
时间窗: During the procedure
Number of Adverse Event(s) that are considered to be major and are attributable to the needle insertion phase of the procedure
次要结局
- Evaluation of the needle readjustments of the device(During the procedure)
- Evaluation of the accuracy of the device(Through study completion, an average of 1 month)
- Evaluation of the safety not related to the procedure(Through study completion, an average of 1 month)