Clinical Trial for the Evaluation of the Accuracy of Augmented Reality Based Neuronavigation System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The degree of 3-dimensional error at each measurement points (mm) after durotomy
研究概览
简要总结
The goal of this clinical trial is to test augmented reality (AR) based neuronavigation system in surgeries for patients of brain neoplasm or cerebral vascular disease. The main questions it aims to answer are:
• AR based neuronavigation system can achieve accuracy that is not inferior to conventional intraoperative navigation system.
Participants will participate the study after informed consent. When participants undergo surgery for their brain tumor, we will set up 2 types of neuronavigation, conventional navigation system and developed AR based neuronavigation system. Surgeon will plan and conduct surgery based on only conventional navigation system, but 3D errors at several selected points between two types of navigation will be measured and analyzed.
详细描述
Being developed AR navigation were reported in our following papers:
- Dho YS, et al., Development of an inside-out augmented reality technique for neurosurgical navigation. Neurosurgical Focus. 2021 Aug 1;51(2):E21. (doi.org/10.3171/2021.5.FOCUS21184)
- Moon HC, et al., Navigation of frameless fixation for gamma knife radiosurgery using fixed augmented reality. Scientific Reports. 2022 Mar 16;12(1):1-0. (doi.org/10.3171/2021.5.FOCUS21184)
This study aims to evaluate the accuracy of anatomical localization of a newly developed augmented reality-based neurosurgery navigation. After 3-dimensional (3D) modeling of the brain of a patient with brain tumor or cerebral vascular disease through 3D image segmentation extraction and modeling, the Augmented Reality (AR)-based navigation developed by this research team can be used with a commercially available visualization device, such as iPad, iPhone, and Hololens2, to evaluate the accuracy.
The AR-based navigation obtained approval from the Ministry of Food and Drug Safety of Republic of Korea (class 2 medical device) in February 2022. Through this clinical tria that compare accuracy with existing conventional intraoperative neuronavigation system, we will evaluate whether it shows equivalent performance to replace the existing navigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or older who underwent MRI or CT scan due to brain tumor or cerebrovascular disease
- •Adult patients aged 18 years or older who need surgical treatment using navigation for brain tumor or cerebrovascular disease
排除标准
- •Cases where application of navigation is not necessary according to the judgment of the researcher or surgeon
- •When the patient or guardian does not agree
- •Patients with anatomical deformation due to previous surgery or requiring emergency surgery
结局指标
主要结局
The degree of 3-dimensional error at each measurement points (mm) after durotomy
时间窗: 6 hours
Tumor's margin, ICA bifurcation, et al.
The degree of 3-dimensional error at each measurement points (mm)
时间窗: 6 hours
Fiducial markers, nasion
次要结局
- Time required to set up and use each navigation(6 hours)
- Non-inferiority of AR-based navigation compared to conventional navigation(12 months)
- Economic analysis for each navigation(12 months)
研究者
Chul-Kee Park
Professor
Seoul National University Hospital