Safety and Performance of the Motorized Spiral Endoscope (PowerSpiral) in Subjects Indicated for Small-bowel Enteroscopy: A PMCF Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 302
- 试验地点
- 10
- 主要终点
- Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice.
研究概览
简要总结
The objective of the SAMISEN study is to assess the performance and safety of diagnostic and therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope (PowerSpiral).
详细描述
The main objective of this registry is to collect data on the safety and performance of the new motorized PowerSpiral device during Post-market Clinical Follow-up. It is assumed that the new device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes.
As clinical performance and efficacy is equally important for the user this study also collects efficacy and handling data of the new device.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Patients with small bowel disease indicated for deep enteroscopy
排除标准
- •Age under 18 years
- •Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
- •Any contraindication to standard enteroscopy
- •Concurrent participation in another competing clinical study
结局指标
主要结局
Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice.
时间窗: up to 12 days
It is assumed that the new device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes. Endoscope (PowerSpiral) in a typical clinical setting within the Intended Use
次要结局
- Number of Participants With Therapeutic Yield(up to 12 days)
- Number of Participants With Procedures That Confirmed Previous Diagnosis(up to 12 days)