Phase 4 Open Label Study Of Indocyanine Green Video Angiography (ICG-VA) And Comparative Utility Of Glow800 And FL800 Intraoperative ICG-VA Tools For Intracranial Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Usefulness of Glow800 Technique
研究概览
简要总结
This is a study looking at a new way to evaluate vascular problems or tumors in brain surgery patients using a standard & approved intravenous dye and augmented reality.
详细描述
This is a study investigating a new technique with an approved medication (ICG or indocyanine green) and using that and a near infrared mode on a standard operating room microscope to see the information provided for vascular or neoplastic (tumor related) neurosurgical problems. The technique uses the data from the microscope and using ICG with augmented reality overlaying the data into the microscope view (this is the new process). The technique is called GLOW800.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •adult patients with a brain lesion requiring surgery and for whom ICG videoangiography would be used
排除标准
- •allergy to ICG (indocyanine green)
研究组 & 干预措施
Treatment group
The treatment group will consist of patients who require a medically necessary craniotomy. If an investigator deems that it will be useful to see blood vessels better with indocyanine green (ICG) videoangiography (VA), patients may be consented for the use if ICG VA using augmented reality (GLOW800). This will not add additional time or risk to their surgery
干预措施: GLOW800 (Device)
Treatment group
The treatment group will consist of patients who require a medically necessary craniotomy. If an investigator deems that it will be useful to see blood vessels better with indocyanine green (ICG) videoangiography (VA), patients may be consented for the use if ICG VA using augmented reality (GLOW800). This will not add additional time or risk to their surgery
干预措施: indocyanine green (ICG) (Drug)
结局指标
主要结局
Usefulness of Glow800 Technique
时间窗: 48 hours
Surgeon assessment of Glow800 compared to ICG-VA in usefulness
次要结局
- Utility in Identifying a lesion(48 hours)
- Surgical workflow(48 hours)
- Additional Cost(48 hours)