NCT03439241已完成不适用
Assessment of the Performance of a New Ostomy Device in Sub-jects Having an Ileostomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- wear time (hours)
研究概览
简要总结
The purpose was to investigate the performance of a new ostomy device measured with a measuring device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Have given written informed consent and in DK: signed a letter of authority
- •Be at least 18 years of age and have full legal capacity
- •Have had their ileostomy for at least 3 months
- •Can use a product with max cut size 45 mm
- •Self-reported problems with leakage (3 x within 14 days)
- •Be willing and suitable (determined by the investigator representative) to use the test product without using a paste/mouldable ring during the test period
- •Must be able to use custom cut product
- •Minimum change of product every third day
- •Get a negative result of a pregnancy test for women of childbearing age (only DK)
排除标准
- •Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy is allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
- •Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
- •Are pregnant or breastfeeding
- •Are participating in other interventional clinical investigations or have previously participated in this investigation Exception: Participation in other Coloplast in-house 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 (CP278) protocol.
- •Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
- •Have known hypersensitivity towards any of the products used in the investigation
研究组 & 干预措施
Silent arm
Experimental
The participants test the new Coloplast ostomy device use the product as they usually would.
干预措施: Coloplast ostomy device (Device)
Active arm
Experimental
The participants test the tnew Coloplast ostomy device and are guided by the measuring device
干预措施: Coloplast ostomy device (Device)
结局指标
主要结局
wear time (hours)
时间窗: 14 days
Wear time is recorded at each baseplate change
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Investigation of a New 1-piece Convex Ostomy ProductStoma IleostomyStoma ColostomyNCT02043782Coloplast A/S38
已完成
不适用
Assessment of new enhanced ostomy devices in real-life settings in subjects having an ileostomyArtificial opening for faecesostomy10017977NL-OMON44434Coloplast A/S20
已完成
不适用
Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-pieceIleostomy - StomaNCT01957553Coloplast A/S130
已完成
不适用
Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or ColostomyIleostomyColostomyNCT02362360Coloplast A/S52
已完成
不适用
Investigation of Newly Developed Ostomy Products in Subjects With IleostomyStoma IleostomyNCT01994902Coloplast A/S129