Evaluation of the Epione Robotic System for Image-guided Percutaneous MSK Procedures of the Pelvis and Spine in USA. A Prospective Study on Feasibility, Safety and Accuracy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Feasability
研究概览
简要总结
The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults.
The main question is the determination of the rate of feasible procedures assisted by the Epione device
Participants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be:
- The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate
- Additional CT or CBCT scans during the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥22 years old,
- •Patients approved for CT- or CBCT-guided MSK procedure in the pelvis or spine (except the cervical area) under general anesthesia,
- •Patients who have signed an IRB-approved informed consent form
- •Patients approved for coverage by their insurance for routine costs involved in this standard of care procedure
- •Inclusion criteria linked to the freehand procedure have been discussed and validated
排除标准
- •Patients with contraindication to undergo general anesthesia,
- •Patients unable to maintain appropriate breathing control,
- •Patients requiring CT- or CBCT-guided percutaneous procedure on target areas other than those indicated
- •Patients unable to fully understand all relevant aspects of the clinical study necessary for their decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response,
- •Pregnant or breast-feeding women,
- •Patients subject to a legal protection measure,
- •Patients already participating in another conflicting interventional clinical study,
- •Patients for whom the scan field of view cannot contain the anatomy of interest, the overlaying skin surface, skin markers and the whole patient reference.
- •Patients having a coagulation abnormalities or bleeding disorder
- •Patients having an active infection on the day of intervention
- •Patients having a history of previous surgery resulting in an existing hardware precluding percutaneous approach
- •Exclusion criteria linked to the freehand procedure have been discussed and validated
研究组 & 干预措施
CT guidance
The procedure is performed under CT guidance.
干预措施: Percutaneous procedure in the MSK structures of the pelvis and/or the spine (Device)
CBCT guidance
The procedure is performed under CBCT guidance.
干预措施: Percutaneous procedure in the MSK structures of the pelvis and/or the spine (Device)
结局指标
主要结局
Feasability
时间窗: 5 months
Rate of successful insertions of the introducer with the assistance of the Epione device.
次要结局
- Safety Adverse Event(6 months)
- Accuracy(5 months)