NCT01957397已完成不适用
Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Degree of Leakage
研究概览
简要总结
To investigate the performance and safety of the three 2-piece convex ostomy appliances
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
- •Subjects interested in participating in the clinical investigation must comply with the following criteria:
- •Are at least 18 years of age and have full legal capacity
- •Have had an ileostomy for at least 3 months.
- •Have used a convex ostomy appliance for the last month
- •Have given written informed consent
- •Have an ileostomy with a diameter of 33mm or less
- •Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks
排除标准
- •Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
- •Have a loop ostomy (also called double-barrel or ostomy with two outlets)
- •Are pregnant* or breastfeeding.
- •Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
- •Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.
- •Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).
- •Known hypersensitivity toward any of the test products
结局指标
主要结局
Degree of Leakage
时间窗: 14 days
The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate)
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With IleostomyIleostomy - StomaNCT01994876Coloplast A/S18
已完成
不适用
Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-pieceIleostomy - StomaNCT01957488Coloplast A/S183
已完成
不适用
Investigation of Newly Developed Ostomy Products in Subjects With IleostomyStoma IleostomyNCT01994902Coloplast A/S129
已完成
不适用
Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With IleostomyStoma - IleostomyNCT01957475Coloplast A/S20
已完成
不适用
Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or ColostomyIleostomyColostomyNCT02675634Coloplast A/S55