Evaluation of the EPIONE Robotic System for Image-guided Percutaneous Bone Procedures A Prospective Study on Feasibility, Safety and Accuracy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Successful Introducer Insertion With the EPIONE 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 bone percutaneous procedures.
详细描述
The objectives are:
- To evaluate the feasibility of the Epione robotic assistance for bone percutaneous procedures.
- To evaluate the safety and the accuracy of the Epione robotic assistance for bone percutaneous procedures.
At least 34 patients (representing at least 67 insertions, as one patient may undergo one or more insertions during the procedure) have been planned for the study. They will be treated by the clinician using the Epione device during a CT-guided percutaneous procedure in musculoskeletal (MSK) structures.
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,
- •Patient with indication of CT-guided percutaneous bone procedure under general anaesthesia validated at a multidisciplinary consultation meeting,
- •Patient who has signed an informed consent form,
- •Patient covered by a social security system,
排除标准
- •Patient with contraindication to general anaesthesia,
- •Patient undergoing a procedure without appropriate breathing control,
- •Patient scheduled for CT-guided percutaneous procedures on head and neck, including skull and cervical vertebrae,
- •Patient with medical, psychosocial or emotional conditions unable to fully understand the study protocol, give an uninfluenced informed consent, or meet the study requirements during its whole duration.
- •Pregnant or breast-feeding women,
- •Patient under legal protection (tutorship, guardianship, …),
- •Patient already participating in another interventional clinical study.
研究组 & 干预措施
Interventional arm
Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device
干预措施: CT-guided bone percutaneous procedure (Procedure)
结局指标
主要结局
Successful Introducer Insertion With the EPIONE Device.
时间窗: Day of the procedure
To evaluate the feasibility of the EPIONE robotic assistance for bone percutaneous procedures based on a definition of conversion to manual technique
次要结局
- Adverse Event(s) (AE)(Up to 1 month)
- Lateral Deviation (mm) Accuracy of the EPIONE Robotic Assistance for Bone Percutaneous Procedures(Day of the procedure)
- Angular Deviation (°)(Day of the procedure)