A Post Market Survey to Detect Information of Adverse Events and Device Malfunctions of AXIOS Stent and Electrocautery Enhanced Delivery System Under Real World Medical Condition in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 40
- 主要终点
- Placement success
研究概览
简要总结
To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who received implant procedure using study device at Japanese site.
排除标准
- 未提供
结局指标
主要结局
Placement success
时间窗: During implant procedure
AXIOS stent is placed in an appropriate position using the delivery system.
Stent retention
时间窗: From implant procedure to removal (a maximum of 60 days)
AXIOS stent stays at the position where it was implanted during the implant procedure.
Safety (Adverse Events and Device Malfunction)
时间窗: From implant procedure to 7 days after removal
Stent lumen patency
时间窗: From implant procedure to removal (a maximum of 60 days)
The lumen of AXIOS stent is patent, and it can be used for drainage etc.
Decreased cyst size
时间窗: From implant procedure to final observation (a maximum of 60 days)
Removal success
时间窗: Removal procedure (a maximum of 60 days after implant procedure)
AXIOS stent can be removed using standard endoscopic snares or forceps.
次要结局
未报告次要终点