A Pilot Study to Evaluate the Safety of MRI Compatible Hardware for Intraoperative MRI-Based Image Guidance for Spinal Procedures
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence of intraoperative adverse events
研究概览
简要总结
This trial investigates the safety and accuracy of using 2 pieces of hardware (a clamp and a needle) that are able to be used with magnetic resonance imaging (MRI) during spinal surgery. During a standard spinal surgery, a computed tomography (CT) scan is used to help plan the placement of surgical instruments used during the procedure or for needle biopsies. Then, the patient is moved to the MRI. For this study, the patient is able to stay in place as the hardware used in this study is able to work with the MRI. Using MRI compatible hardware may allow for an extra degree of safety and facilitate better surgical workflow.
详细描述
PRIMARY OBJECTIVE:
I. To document the safety of utilizing MRI compatible hardware for intraoperative MRI-based image guidance to perform percutaneous spinal procedures.
SECONDARY OBJECTIVE:
I. To determine the accuracy of the MRI-based image guidance.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Patients undergoing percutaneous spinal procedures requiring image guidance at MD Anderson
- •Age > 18 years old. (The indication for this technique is controversial in skeletally immature patients.)
- •All diagnoses are eligible
- •Vertebral body site to be treated located from T2 to T12
- •Signed informed consent
排除标准
- •Requires open spinal procedure or a percutaneous procedure without the use of image guidance
- •Unable to tolerate general anesthesia and prone position
- •Unable to undergo MRI scan of the spine
研究组 & 干预措施
Device feasibility (MRI-guided surgery)
Patients undergo standard of care spine surgery with MRI-based image guidance.
干预措施: Magnetic Resonance Imaging (Device)
Device feasibility (MRI-guided surgery)
Patients undergo standard of care spine surgery with MRI-based image guidance.
干预措施: Therapeutic Conventional Surgery (Procedure)
结局指标
主要结局
Incidence of intraoperative adverse events
时间窗: During surgery
Safety will be assessed as a dichotomous variable. Frequencies and descriptive statistics of the outcomes under study will be performed. 95% confidence intervals will be computed. Other ad-hoc analyses may be performed as well.
次要结局
未报告次要终点