NCT01232933已完成不适用
Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Performance target: the catheter tip will be located in the lower 1/3 of the SVC or at the cavoatrial junction as evaluated by fluoroscopy with a VPS bullseye at least 90% of the time
研究概览
简要总结
Subjects meeting study requirements will be consented and have their PICC catheter placed using navigational technology and the tip placement confirmed with radiographic imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Adult with a PICC placement order
排除标准
- •Pregnant or nursing
- •Abnormal ECG
- •Anatomic irregularities or history that would prevent proper placement
- •Subject does not consent to photography, release of data and x-ray confirmation
- •Subject does not understand or is not willing to sign informed consent for the VPS implant procedure and data release
结局指标
主要结局
Performance target: the catheter tip will be located in the lower 1/3 of the SVC or at the cavoatrial junction as evaluated by fluoroscopy with a VPS bullseye at least 90% of the time
时间窗: participants are followed until catheter tip confirmation via fluoroscopy is completed which is on average one hour from procedure initiation
次要结局
- The VPS will provide a blue bullseye indicator 80-90% of the time(participants are followed until catheter tip confirmation is completed which is on average one hour from the start of the procedure)
研究者
研究点 (2)
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