Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click in 130 Subjects With an Ileostomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 17
- 主要终点
- Preference
研究概览
简要总结
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
详细描述
The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •1.Have given written informed consent and letter of authority (DK only)
- •2.Be at least 18 years of age and have full legal capacity.
- •3.Be able to handle the products her/himself
- •4.Have an ileostomy with a diameter between 10 and 40 mm.
- •5.Have had their ostomy for at least three months.
- •6.Be willing to use minimum 2 base plates every week
- •7.Currently use 2-piece flat mechanical coupling product with open bag 8
- •11.Negative result of a pregnancy test for women of childbearing age (only DK)
排除标准
- •1.Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- •2.Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- •3.Is pregnant or breastfeeding.
- •4.Is participating in other interventional clinical investigations or have previously participated in this investigation
- •5.Has participated in the previous explorative study CP234
- •7.Known hypersensitivity towards any of the test products
- •8.Currently suffering from peristomal skin problems (i.e.bleeding or red and broken skin)
研究组 & 干预措施
Treatment sequence 1, First Coloplast Test product
Subjects first allocated to Coloplast Test product will after cross-over test SenSura
干预措施: Coloplast test product (Device)
Treatment sequence 1, First Coloplast Test product
Subjects first allocated to Coloplast Test product will after cross-over test SenSura
干预措施: SenSura (Device)
Treatment seqence 2; First SenSura
Subjects first allocated to SenSura will after cross-over test Coloplast Test product
干预措施: Coloplast test product (Device)
Treatment seqence 2; First SenSura
Subjects first allocated to SenSura will after cross-over test Coloplast Test product
干预措施: SenSura (Device)
结局指标
主要结局
Preference
时间窗: 21+1 days
The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura.
次要结局
未报告次要终点