Non-Interventional, International, Post-Marketing Clinical Follow-up Study on the Stoma Appliance Flexima®/Softima® 3S
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- evaluation of the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up
研究概览
简要总结
To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up.
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.
详细描述
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 who has had a colostomy or an ileostomy or a jejunostomy or an urostomy for at least 1 month
- •Patient agreeing to participate to the study and having signed the informed consent form/information letter in accordance with local requirements
- •Patient for whom the use of Flexima®/Softima® 3S has already been decided within the regular planning of his treatment
排除标准
- •Patient with cognitive problems, according to the investigator, preventing him from answering a questionnaire or for whom the evaluation could be a problem
- •Patient taking part in another clinical evaluation
- •Patient having more than one stomy
- •Patient vulnerable and under legal protection
- •Patient having had an known allergy to one of the components of the appliance
- •Patient previously using Flexima®/Softima® 3S
结局指标
主要结局
evaluation of the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up
时间窗: the questions will be asked to the patient at each follow up visits (= at 1 month, 3 months and 6 months).Total Score will range from 3 to 12. A total score of 9 or more will define appropriate overall satisfaction.
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S. For each item, the patient will evaluated the product thanks to a 4 points scale question (very good (4)/good(3)/ poor(2)/ very poor(1))
次要结局
未报告次要终点