3D Rotational CT Angiogram With Embolization Guidance and CBCT in Prostatic Artery Embolization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time for Prostatic Artery Catheterization
研究概览
简要总结
The purpose of this research study is to learn about how cone-beam Computerized Tomography scans (X-ray images taken from different angles) work together with an embolization guidance software (helps the doctor see the arteries that feed the prostate)to find and see arteries in the prostate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient is age 50 to 79, inclusive
- •Patients undergoing Prostate artery embolization for BPH or urinary retention -Patient has signed informed consent.
排除标准
- •Patients with biopsy proven prostate cancer
- •Patient weight of >300 lbs
研究组 & 干预措施
3D Angiogram + Emboguide
Participants will receive cone-beam CT 3D Emboguide: cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels.
干预措施: cone-beam CT 3D Emboguide (Device)
No 3D Angiogram + Emboguide
Embolization will be guided by a standard of care CT.
干预措施: cone-beam CT 3D Emboguide (Device)
结局指标
主要结局
Time for Prostatic Artery Catheterization
时间窗: hour 2
For the cases using Emboguide this will be measured as the time from which the Emboguide is displayed on the live fluoroscopy to the time of prostatic artery catheterization. Emboguide display is in addition to the angiogram roadmap display. For the control cases this will be measured as the time from which the angiogram is displayed on the live fluoroscopy to the time of prostatic artery catheterization.
次要结局
未报告次要终点
研究者
Shivank Bhatia
Assistant Professor of Clinical Radiology & Urology
University of Miami