NCT00294450已完成2 期
Pouching of Fistula - a Non-comparative, Multi-center Investigation
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 14
- 主要终点
- Nurse's preference to use the test product in the future
研究概览
简要总结
The purpose of this investigation is to carry out a clinical evaluation of a newly developed fistula pouching system's ability to function as a good pouch for fistulas, with the opening on the skin of the stomach or in a wound on the skin of the stomach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •18 years or older
- •Capable of giving informed consent
- •Have to be hospitalized
- •Have a fistula with the opening on the skin in the abdominal area
排除标准
- •Pregnant and/or breast-feeding
- •Receiving radiation- or chemotherapy during the investigation period
结局指标
主要结局
Nurse's preference to use the test product in the future
时间窗: Up to 18 days
次要结局
未报告次要终点
研究者
研究点 (14)
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