CP216: An Exploratory Investigation of Convex Ostomy Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Degree of Leakage
研究概览
简要总结
Coloplast A/S has developed a new ostomy device in 8 versions.
The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices.
The secondary objective is to investigate several performance and safety parameters of the various devices.
The aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed.
Given that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development.
The investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users.
Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each device will be tested for 7 (± 2) days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 old
- •Have signed the declaration of informed consent
- •Have an ileostomy in a concave area
- •Have had an ileostomy for at least three months
- •Have used convex plates (for convex users) or flat plates (for flat plate users) for the last month
- •Be users of 1-piece or 2-piece open ostomy devices
- •Have an ileostomy with a diameter of less than 33 mm
排除标准
- •Are pregnant or breast-feeding
- •Have a double-loop ileostomy
- •Have known hypersensitivity or allergy to the devices' component ingredients
- •Are receiving/have received radiation treatment and/or chemotherapy within the last 3 months.
- •Are receiving/have received local peristomal or systemic steroid treatment within the last month
- •Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)
结局指标
主要结局
Degree of Leakage
时间窗: One week
The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate. The scale was developed by Coloplast A/S
次要结局
未报告次要终点