Investigation of a New Rectal Catheter for Users of Transanal Irrigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Was it Possible to Perform Transanal Irrigation?
研究概览
简要总结
The clinical investigation is an exploratory, randomised controlled, open-labelled, crossover investigation.
The clinical investigation will be conducted as a multi-centre clinical investigation in two different clinical investigation sites in Denmark.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •Has given written Informed Consent
- •Is at least 18 years old
- •Has full legal capacity
- •Has used Trans Anal Irrigation (TAI) with balloon catheter for at least 4 weeks prior to inclusion
- •Performs TAI minimum 3 times/week
- •Is able to follow study procedures assessed by investigator
排除标准
- •Has known anal or colorectal stenosis
- •Has active/recurrent colorectal cancer
- •Is within 3 months of anal or colorectal surgery
- •Is within 4 weeks of endoscopic polypectomy
- •Has ischaemic colitis
- •Has acute inflammatory bowel disease
- •Has acute diverticulitis
- •Is participating in any other clinical study that may interfere with this study (assessed by investigator).
- •Is pregnant or breastfeeding
研究组 & 干预措施
Investigational device - newly developed TAI catheter.
CP362 Test Catheter: The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen® Plus TAI system.
干预措施: CP362 Test Catheter (Device)
Peristeen Plus
Comparator catheter: The Peristeen® Plus rectal balloon catheter is used together with the CE-marked Peristeen® Plus TAI system.
结局指标
主要结局
Was it Possible to Perform Transanal Irrigation?
时间窗: Evaluated at Visit 1 and Visit 2 (within a time duration of up to 17 days)
After visit 1 and visit 2, the primary endpoint, defined as if it was possible to perform transanal irrigation, was answered by a yes/no answer.
次要结局
未报告次要终点