Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation as an Adjunct to Standard Flat Panel Display
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Standard System Usability Score on a Likert Scale
研究概览
简要总结
Medical images used to guide treatment of tumor(s) are presently displayed on flat-panel monitors (like screens used with computers). This protocol will evaluate, using a new headset to view the images in true 3D ("360 degrees"), while using standard flat panel monitors as usual (in accordance with standard of care). The headset is combined with a mini-global positioning system (GPS)-like system to help navigate to treat tumor(s). This evaluation is to show that the headset has potential to provide guidance and navigation information that can improve the treatment of tumor(s) with heat.
详细描述
This protocol will clinically evaluate new 3D holographic guidance and navigation for percutaneous ablation of solid tumors to ultimately overcome limitations of displaying images on 2D flat-panel monitors ("flat screens"). 3D Holographic percutaneous ablation (3D HPA) provides real-time, 360° visualization for guidance and navigation of tracked interventional instruments augmented to the operative site. In this preliminary protocol, 3D HPA will be evaluated as an adjunct to flat-screen display of conventional images used for guidance (ultrasound, fluoroscopy, CT), in accordance with standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Not pregnant
- •Willing and able to give informed consent prior to enrollment. This includes media release form.
- •Has met all criteria to undergo percutaneous tumor ablation.
排除标准
- •Not willing or able to give informed consent
- •Patients with pacemakers or automated implantable cardioverter defibrillator (AICDs).
结局指标
主要结局
Standard System Usability Score on a Likert Scale
时间窗: 1 day
The surgeons and staff completing the intervention will rate the usability of the system. An average score greater than 3 will indicate acceptability of the 360 degree display.
次要结局
未报告次要终点