NCT05644912已完成不适用
Exploratory Investigation on a Novel Catheter
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Catheter stay in place
研究概览
简要总结
An exploratory, pre-market, open, prospective, interventional, clinical investigation at a limited number of centers for proof of concept of a new catheter.
In this proof of concept investigation, subjects experienced in using transanal irrigation (TAI) with a balloon catheter will be using study catheters at two occasions to primarily study if the catheter will stay in place during the water instillation when performing TAI.
Each subject will be followed during approximately one week, depending on the usual time between their TAI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent.
- •Female and male aged 18-80 years.
- •Patients successfully treated by TAI with Navina Smart system for at least 3 months and/or stable in therapy.
- •Patients considered suitable to participate by investigator.
- •Able to read, write and understand information given to them regarding the study.
排除标准
- •Involvement in the planning and conduct of the clinical investigation (applies to both Wellspect HealthCare staff and staff at the study site).
- •Previous enrolment in the present clinical investigation.
- •Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last month, that may interfere with the present clinical investigation.
- •Severe non-compliance to Clinical Investigation Plan as judged by the investigator and/or Wellspect HealthCare.
- •Significant cardiovascular and/or other significant co-morbidities which could be negatively affected by the use of the investigational product.
- •Known anal or colorectal stenosis.
- •Active inflammatory bowel disease.
- •Acute diverticulitis.
- •Colorectal cancer.
- •Ischemic colitis.
- •Any anal or colorectal surgery within the previous 3 months.
- •Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.
- •Any condition, as judged by the investigator, which might make follow-up or investigations inappropriate.
- •Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.
结局指标
主要结局
Catheter stay in place
时间窗: 1 week
Does the catheter stay in place during water instillation? Yes/No
次要结局
- Bowel emptying performance(1 week)
- Leakage(1 week)
研究者
研究点 (2)
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