NCT06237686已完成不适用
Clinical Investigation Exploring Two Ostomy Product Prototypes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Primary Objective
研究概览
简要总结
Two ostomy product prototypes (Test product A and B) will be tested in this investigation.
All subjects will test both Test product A and B, with a minimum of 7 days apart. In total, each subject will be enrolled in the investigation for 8 days +3 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Has given written informed consent
- •Is at least 18 years of age and has full legal capacity
- •Has had an ileostomy for more than 3 months
- •Has suitable peristomal skin area (assessed by investigator)
- •Is currently using flat SenSura Mio 1-piece or 2-piece
- •Has used flat SenSura Mio 1-piece or 2-piece for at least 14 days
- •Has a stoma size less than 45mm in diameter
排除标准
- •Is currently receiving or have within the past 60 days received radio- and/or chemotherapy (Low doses radio- and/or chemotherapy (Assessed by Principal Investigator) is allowed. for indications other than cancer)
- •Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g. lotion or spray or systemic steroid (tablet/injection) treatment
- •Is pregnant or breastfeeding
- •Has dermatological problems in the peristomal area (assessed by investigator)
- •Participates in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol
- •Has any known allergies towards ingredients in the investigational device
结局指标
主要结局
Primary Objective
时间窗: 4 hours
Test product A and B's ability to swell around the stoma (assessed by photo/video)
次要结局
未报告次要终点
研究者
研究点 (2)
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