Prospective Use of Philips iSuite for Interventional Procedures
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Needle placement efficiency into target lesion
研究概览
简要总结
This research study is being done to look at new MRI imaging guidance software, Philips Interventional iSuite software, to see if using will improve the physician's ability to quickly place and guide needle tip position for biopsies and ablations.
详细描述
The purpose of this study is to evaluate Philips Interventional iSuite software used for MRI guided procedures in the MRI suite. The real-time MRI Imaging software will be used during an MRI procedure to take continuous pictures.
The Philips Interventional iSuite software package has not received FDA 510(k) clearance. The Investigator will be evaluating and publishing on the use of this software as a clinical aid in performing interventional procedures within the MR suite. The primary evaluation will be weighted toward enhanced facilitation of ablation procedures. However, the software will not replace standard MR imaging for final confirmation of needle tip position and ablation margins.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients already scheduled for a percutaneous MR guided procedure
排除标准
- •Pregnant Women
研究组 & 干预措施
MRI guided procedure software evaluation
Evaluate the workflow and effectiveness of the Philips Interventional iSuite software during biopsies and/or ablations versus standard MR imaging in aiding needle placement.
干预措施: MRI guided procedure software evaluation (Device)
结局指标
主要结局
Needle placement efficiency into target lesion
时间窗: Baseline (completion of MRI-guided biopsy and /or ablation procedure)
Needle placement efficiency record time to final needle position, and compare overall similarity of use with current CT guided intervention during the interventional procedure in order to determine how the iSuite may facilitate intervention with the MRI environment. Each operator will fill out a short questionnaire after each intervention.
次要结局
- Software ease of use in targeting lesion for treatment(Baseline (completion of MRI-guided biopsy and /or ablation procedure))
研究者
David A. Woodrum
Principal Investigator
Mayo Clinic