Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Frequency of Ballooning in the Morfeus and SenSura Test Period.
研究概览
简要总结
The aim of the current clinical investigation is to evaluate a new filter.
详细描述
The new filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.
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
- •Be at least 18 years of age and have full legal capacity.
- •Have given written informed consent.
- •Be able to fill in the Case Report Form.
- •Be colostomy operated and have had a stoma for at least 6 months.
- •Experience ballooning at least once per week.
- •Be able to manage the bags themselves (application, removal).
- •Be able to use a flat base plate.
- •Have a stoma with a diameter less than 60 mm
排除标准
- •Persons who irrigate
- •Currently suffer from peristomal skin problems (i.e. bleeding or broken skin).
- •Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- •Pregnant or breastfeeding.
- •Participate in other test at the same time.
结局指标
主要结局
Frequency of Ballooning in the Morfeus and SenSura Test Period.
时间窗: Daily or at every change of bag in a period of a maximum of 28 days
Data will not be recorded at specific time points due to individual changing patterns (1-3 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.
次要结局
未报告次要终点