Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 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 two newly developed convex 1-piece 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 must comply with the following criteria in order to participate in the investigation:
- •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 33 mm or less
- •Have experience 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 (adreno-cortical hormone) in the peristomal area
- •Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin))
- •Are currently participating in another clinical investigation or has previously participated in this investigation
研究组 & 干预措施
First Coloplast Test 1
The subjects first test their own product to collect a baseline measurement
The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2
干预措施: Coloplast Test 1 (Device)
First Coloplast Test 1
The subjects first test their own product to collect a baseline measurement
The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2
干预措施: Coloplast Test 2 (Device)
First Coloplast Test 2
The subjects first test their own product to collect baseline measurements
The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1
干预措施: Coloplast Test 1 (Device)
First Coloplast Test 2
The subjects first test their own product to collect baseline measurements
The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1
干预措施: Coloplast Test 2 (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 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)
次要结局
未报告次要终点