An Open-labelled, Randomised, Controlled, Comparative, Multi-national, Cross-over Study Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared to 2-piece Standard Care Ostomy Products
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 11
- 主要终点
- Degree of Output Under the Base Plate (Leakage).
研究概览
简要总结
The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.
The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates.
The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates.
Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods.
The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period.
100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Have given written Informed Consent
- •Is at least 18 years old
- •Has the mental capacity to understand the study guidelines and questionnaires
- •Has had their ileostomy for at least 3 months
- •Has an ileostomy with a diameter between 19-40 mm
- •Is currently using a flat 2-piece product with with mechanical coupling
- •Is able to change the base plate by themselves or with help from a caregiver (e.g. spouse)
- •Has experienced leakage under the base plate at least once a week over the last 2 weeks
排除标准
- •Is pregnant or breast-feeding
- •Currently receiving or has within the past 2 months received radio- and/or chemotherapy
- •Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted)
- •Is currently using a convex base plate
- •Participating in other clinical studies or has previously participated in this study
研究组 & 干预措施
Standard Care base plate
Standard care are the participants own product and can have several manufacture and brand names
干预措施: Standard Care base plate (Device)
New ostomy base plate (SS)
SS = New ostomy base plate. Due to company confidentiality the product is called SS and this is not short for any name
干预措施: New ostomy base plate (SS) (Device)
结局指标
主要结局
Degree of Output Under the Base Plate (Leakage).
时间窗: Each test product was assessed for 2 weeks.
Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).
次要结局
未报告次要终点