The Clinical Value of Ultrasound based Navigation update in cranial resection procedures
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Brainlab AG
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- To determine brain shift compensation by assessing the navigation accuracy after dura opening before and after utilizing the Navigation Update feature of Brainlab’s Ultrasound Navigation software.
研究概览
简要总结
Surgical removal is often the main treatment for tumors. In order to completely remove the entire tumor, it is vital to ensure visualization into the brain to review the borders of the tumor and to not harm healthy tissue. Neuronavigation is a well-accepted method to view inside the brain during surgery. This works like a GPS system providing the neurosurgeon with intraoperative guidance based on preoperatively acquired MRI which are registered to the patient’s anatomy. However, accuracy is affected due to brain shift or the movement of the brain after opening the dura or resection of the tumor. Intraoperative ultrasound navigation can be used to compensate for brain shift by providing updated real-time accurate information of the surgical field. the real-time ultrasound is fused with the MRI to update its accuracy. This project is intended to quantify the hypothesized improvement in navigation accuracy using Brainlab’sUltrasound Navigation software and determine if using a navigation update feature can compensate for brainshift and therefore improve navigation accuracy and hence, positively influence extent of resection.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Intra axial supratentorial brain tumors planned to undergo tumor resection surgery.
排除标准
- •< 18 years of age, all other tumor lesions not described in the inclusion criteria.
结局指标
主要结局
To determine brain shift compensation by assessing the navigation accuracy after dura opening before and after utilizing the Navigation Update feature of Brainlab’s Ultrasound Navigation software.
时间窗: intraoperative only
次要结局
- Extent of resection(24hrs post surgery)
- Factors influencing the accuracy benefit(intraoperative)
