NCT02944916已完成不适用
Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders
BBraun Medical SAS0 个研究点目标入组 15 人开始时间: 2016年11月10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
- 15
- 主要终点
- Success of the trans anal irrigation (TAI) procedure
研究概览
简要总结
The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each irrigation
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 signed an informed consent
- •Patient having neurologic or non neurologic bowel disorders, being initiated to TAI and practicing TAI with Peristeen® for the management of her/his bowel disorders, for at least 6 weeks, with satisfying results.
- •Patient practicing TAI on the basis of 1 procedure/ week as a minimum or more frequently
- •Patient capable to perform the procedure of transanal irrigation himself or with the help of a caregiver
- •Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
- •Patient agrees to test IryPump® Set R for a time corresponding to 5 consecutive irrigations and a maximum of 4 weeks.
- •Patient covered by social security
排除标准
- •Patient with bowel obstruction
- •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
Success of the trans anal irrigation (TAI) procedure
时间窗: Duration of the study per patient will correspond to the realisation of 5 consecutive TAI in a maximum of 41 days of follow up
The patient will practice TAI following his usual frequency (depending on his intestinal transit). After each TAI, the patient will evaluate the success of the procedure (defined as satisfying output evacuation of the bowel according to the patient usual pattern in term of volume of water instilled and absence of leakages between 2 irrigations).
次要结局
未报告次要终点
研究者
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