Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Time to reach the target
研究概览
简要总结
Treatment of vascular malformations requires the placement of a needle within anatomically non well defined, pathological vessels, which may be as small as 1 mm, with the current state of the art relying exclusively on two dimensional fluoroscopy images for guidance. The investigators hypothesize that the combination of stereotactic image guidance with existing targeting methods will result in faster and more reproducible needle placements.
详细描述
This prospective study aims to investigate the feasibility of the utilization of stereotactic image guidance technology for the needle based percutaneous treatment of peripheral vascular malformations. The specific device to be utilized is the CAS-One IR system, CE marked for use with needle based procedures in combination with medical image data including MRI data, as required by this study.
Utilizing feedback from the stereotactic image guidance system, the interventionalist will attempt to place the needle within the malformation. The position and orientation of the needle relative to the anatomy will be displayed on 2D slices from the MRI, as well as relative to a 3D volume rendering of the patient anatomy constructed from MRI data. The position of the needle relative to the desired position within the malformation will be evaluated utilizing fluoroscopy.
If necessary the position of the needle will be adjusted, this adjustment can be performed utilizing navigated feedback or standard fluoroscopy feedback at the discretion of the physician. The final position of the needle will be confirmed on intra-operative DSA imaging and the sclerosant will be applied according to standard clinical protocols.
This single-centre pilot study will involve a total of 10 patients suffering from peripheral vascular malformations. Only non-emergency adult patients will be considered for inclusion in this trial. Inclusion will be at the discretion of the treating physician and patient. As the study is designed as a pilot trial, no comparator is considered and no blinding performed. The trial will be performed over a period of nine months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with venous or mixed venous-lymphatic malformation
- •Patients which are regular scheduled for a percutaneous treatment of a vascular malformation
- •Informed Consent as documented by signature
排除标准
- •Age < 18 years
研究组 & 干预措施
Experimental
Image guided needle placement into vascular malformations based on MRI
干预措施: Image guided needle placement (Device)
结局指标
主要结局
Time to reach the target
时间窗: During the intervention (duration approx. 90 minutes on average)
Time from start of targeting to alcohol embolization in minutes
次要结局
- Contrast agent volume(During the intervention (duration approx. 90 minutes on average))
- Reason to change to standard approach(During the intervention (duration approx. 90 minutes on average))
- System Usability Score (SUS)(Directly after the intervention (60 minutes afterwards at the latest))
- Radiation time(During the intervention (duration approx. 90 minutes on average))
- Radiation dose(During the intervention (duration approx. 90 minutes on average))
- Number of attempts(During the intervention (duration approx. 90 minutes on average))