NCT03108105已完成不适用
Multicenter Pilot Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy
BBraun Medical SAS2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Description of efficacy in terms of stool collection and leakage prevention
研究概览
简要总结
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient is at least 18 years old
- •Patient having a colostomy with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches
- •Patient having a colostomy for at least 1 month
- •Patient using a flat ostomy appliance
- •Patient having a stoma protusion smaller than or equal to 1.5 cm
- •Patient capable to apply and remove the appliance himself or with the help of a caregiver (except health care professional)
- •Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
- •Patient agreeing to test the new appliance during the evaluation phase (14±3 days)
- •Patient covered by social security
排除标准
- •Patient experiencing repeated leakages with the usual pouching system
- •Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
- •Patient receiving or having received, within the last month, chemotherapy, radiotherapy or corticotherapy
- •Patient already participating in another clinical study or who have previously participated in this investigation
- •Pregnant or breast-feeding woman
研究组 & 干预措施
AOS-C2001-B
Experimental
A new 2-piece appliance composed with 2 parts: a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day)
干预措施: AOS-C2001-B (Device)
结局指标
主要结局
Description of efficacy in terms of stool collection and leakage prevention
时间窗: At least 1 time per day during 14±3 days
After each change of the investigational product, the patient will describe on a 4-point scale the type of capsule cap cover removal
次要结局
未报告次要终点
研究者
研究点 (2)
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