NCT02507726已完成不适用
Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy
BBraun Medical SAS2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector
研究概览
简要总结
This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.
详细描述
Primary outcome Measure:
To describe Investigational Device performance in term of level of leakage under the skin protector
Secondary Outcome Measure:
- Assessment of the condition of peristomal skin
- Assessment of other performance criteria
- Assessment of AEs for each patient
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •patient is at least 18 years old,
- •patient having a colostomy or an ileostomy for at least 1 month,
- •patient having a stoma's diameter inferior to 45 mm,
- •patient having a flat or flushed or slightly retracted stoma,
- •patient using currently a one-piece soft convex or standard ostomy appliance with closed or drainable bags,
- •patient using a minimum of 1 product per day with closed pouches or minimum 1 product per two days with drainable pouches
- •patient capable to apply and remove the pouch 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 investigational product during 14(±3) days.
- •patient covered by social security
排除标准
- •patient experiencing repeated leakages with his current appliance,
- •patient receiving or having received, within the last month, chemotherapy or radiotherapy or corticotherapy,
- •patient having a deeply retracted stoma,
- •patient currently suffering from peristomal skin complications (bleeding or severe irritation or red and broken skin at the time of inclusion),
- •patient already participating in another clinical study or who have previously participated in this investigation,
- •pregnant or breast-feeding woman
结局指标
主要结局
Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector
时间窗: 14 +- 3 days
次要结局
- Peristomal skin evaluation with DET score scale(baseline and 14 +- 3 days)
- Investigational product conformability as measured by a Likert scale score (1-4)(14 +- 3 days)
- Use of Investigational Product in the future as measured by a Likert scale score (1-2)(14 +- 3 days)
- Residues on the skin after each Investigational Product removal as measured by a Likert scale score (1-4)(14 +- 3 days)
- Ease of Investigational Product handling as measured by a Likert scale score (1-4)(14 +- 3 days)
- Investigational product adhesivity as measured by a Likert scale score (1-4)(14 +- 3 days)
- Convex ring suppleness of the Investigational product as measured by a Likert scale score (1-4)(14 +- 3 days)
- Investigational Product leakage prevention as measured by a Likert scale score (1-4)(14 +- 3 days)
- Investigational Product overall satisfaction as measured by a Likert scale score (1-4)(14 +- 3 days)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(baseline and 14 +- 3 days)
- Investigational product flexibility as measured by a Likert scale score (1-4)(14 +- 3 days)
- Feeling of Investigational Product security as measured by a Likert scale score (1-4)(14 +- 3 days)
- Investigational product wear time(14 +- 3 days)
- Connection of the Investigational Product belt to the belt hear as measured by a Likert scale score (1-4)(14 +- 3 days)
- Investigational Product wearing comfort as measured by a Likert scale score (1-4)(14 +- 3 days)
研究者
研究点 (2)
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