NCT03929978撤回不适用
A Multi-Centre Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Baby Device in Subjects With a Stoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Median wear time
研究概览
简要总结
The aim of the non-interventional Post Market Clinical Follow-up (PMCF) study is to follow performance and safety of the newly marketed SenSura® Mio Baby device in a real-life setting.
The objective is to evaluate the SenSura® Mio Baby device performance and safety.
详细描述
The aim of the non-interventional Post Market Clinical Follow-up (PMCF) study is to confirm the established safety and performance of the newly marketed SenSura® Mio Baby device in a real-life setting.
The objective is to evaluate wear time of SenSura® Mio Baby device and other secondary endpoints related to performance, and safety of the device.
Primary endpoint:
• Median wear time
Secondary endpoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Week 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria and justification hereof:
- •Have a colostomy, ileostomy (jejunostomy), loop stoma, or two stomas placed closely together
- •Have given written informed consent (the legal authorized representative of the subject)
排除标准
- •The subjects are not allowed to participate in case they:
- •Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
结局指标
主要结局
Median wear time
时间窗: 3 weeks
次要结局
未报告次要终点
研究者
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