Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 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
研究组 & 干预措施
Coloplast Test 1
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2
Finally the all subject test Coloplast Test 3
干预措施: Coloplast Test 1 (Device)
Coloplast Test 1
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2
Finally the all subject test Coloplast Test 3
干预措施: Coloplast Test 2 (Device)
Coloplast Test 1
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2
Finally the all subject test Coloplast Test 3
干预措施: Coloplast Test 3 (Device)
Coloplast Test 2
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1
Finally the all subject test Coloplast Test 3
干预措施: Coloplast Test 1 (Device)
Coloplast Test 2
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1
Finally the all subject test Coloplast Test 3
干预措施: Coloplast Test 2 (Device)
Coloplast Test 2
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1
Finally the all subject test Coloplast Test 3
干预措施: Coloplast Test 3 (Device)
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