Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge.
研究概览
简要总结
Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial
详细描述
An Investigator initiated, prospective, randomized, multi-site study to evaluate the clinical utility of radiation exposure reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Member of the interventional care team
- •Elective peripheral procedure
- •The access site is the femoral artery
- •The treatment area is at or distal to the iliac artery
排除标准
- •Individuals who are not yet adults, pregnant women, or prisoners.
- •Urgent and emergent cases
研究组 & 干预措施
Traditional Lead Apron and Shields
These procedures will be have no intervention. The study team will use the traditional lead apron and shields in peripheral cases.
Rampart IC System
The study team will use the Rampart IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases.
干预措施: Rampart IC System (Device)
结局指标
主要结局
The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge.
时间窗: Intraprocedural
The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge. The two methods being compared are traditional lead aprons and shields and the RAMPART IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases.
次要结局
- The difference in radiation exposure to the care team on a per body segment analysis using a Raysafe i3 dosimeter badge.(Intraprocedural)