Augmented Reality Real-Time Guidance for MRI-Guided Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Safety of using the augmented reality needle guidance system will be evaluated through assessment of procedure related adverse events that occur within 7 days of the procedure.
研究概览
简要总结
The purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing MRI-Guided needle procedures.
详细描述
This pilot clinical study is designed to evaluate the feasibility of using a needle guidance system during MRI-guided procedures in up to 12 patients. The MRI-compatible needle guidance system was developed under an NIH funded SBIR Phase II grant. This system has been evaluated by our Interventional Radiology team in phantom, volunteer, and cadaver studies which showed potential benefit of use in patients. Inclusion of the needle guidance system will not change the standard of care or substantively affect procedural technique as currently performed. This system provides the operator with an augmented reality (AR) display to better visualize the needle entry point and trajectory as it is inserted toward the target. This additional information could improve needle placement accuracy and shorten procedural time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, ages 3 to 21
- •Patient referred to Interventional Radiology for image-guided needle injection, aspiration, or biopsy.
排除标准
- •Patients who are unable to give informed consent themselves or through their parents.
- •Patients under 3 years of age
- •Patients over 300 pounds.
- •Patients who are claustrophobic and unable to tolerate MRI-guided procedure.
- •Contraindications to MRI such as MR-unsafe implants.
结局指标
主要结局
Safety of using the augmented reality needle guidance system will be evaluated through assessment of procedure related adverse events that occur within 7 days of the procedure.
时间窗: 7 days
Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system.
时间窗: 1 day
次要结局
- Procedure time(1 day)
- Number of MRI scans(1 day)
- Clinical impressions of the system use and utility(1 Day)
研究者
Karun Sharma MD
Director of Interventional Radiology
Children's National Research Institute