Merging Augmented Reality and Neuroimaging to Improve Patient Safety and Outcomes for Neurosurgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Mean accuracy (in mm) of SEPS placement
研究概览
简要总结
This study involves using a augmented reality (AR) system to assist in the placement of a subdural evacuating portal system (SEPS). In the first part of the study, all participants will have skin marking of an AR-guided and non-AR-guided site to determine feasibility and method accuracy. In the second part, subjects will be randomized to AR-guided and non-AR-guided SEPS placement to determine efficacy.
详细描述
Chronic/subacute subdural hematoma (SDH) is one of the most common diseases encountered in neurosurgical practice. However, there is little consensus on first-line treatment. The SEPS was developed to implement a minimally invasive approach to drainage. New imaging technologies, such as augmented reality (AR) interfaces, can provide anatomical models and can help visualize hidden structures. The hope is that this study can give insight on whether AR-guidance can be used to improve SEPS placement, which can lead to higher volume drainage, greater symptomatic improvement, and decreased hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Unilateral or Bilateral subdural hematoma that is planned to be treated by SEPS
- •Exclusion Criteria
- •Unable to have CT scan
- •Pregnancy
排除标准
- 未提供
结局指标
主要结局
Mean accuracy (in mm) of SEPS placement
时间窗: Intra-procedural and up to 24 hours post procedure
Comparison of measurements obtained by standard of care surface measurements and placement using AR guidance, and post placement CT scans.
次要结局
- Change in size (mm) of subdural hematoma(Pre-procedure and 24 hours after SEPS placement)
- Change in symptom score(Assess at 24 hours status post SEPS placement and again at 1 month)
- Length of hospital stay(Approximately 2 to 5 days)
研究者
Vivek P. Buch
Assistant Clinical Professor of Neurosurgery
Stanford University