An Un-controlled, Prospective, Multi-center, Post Market Clinical Follow-up Investigation to Confirm Performance and Safety of Navina Mini, a New CE-marked Low-volume Transanal Irrigation (TAI) Device.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Patient satisfaction
研究概览
简要总结
This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use during a period of four weeks.
Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact.
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
- •Signed informed consent
- •Anal incontinence or faecal outlet problems without any pathological obstruction in the ano-rectum.
- •Symptom duration of > 6 months
- •Adult male and females >18 years old
- •Patient can communicate in written and oral Swedish language
排除标准
- •Subjects treated with high volume TAI i.e., volume > 250 ml
- •Pregnancy at the time of enrollment
- •Participating in another clinical investigation interfering with this investigation
- •Subjects with active, symptomatic inflammatory bowel disease, radiation proctitis and or active perianal fistula disease
- •Rectal bleeding of uncertain origin or active hemorrhoidal bleeding
- •< 6 months after anal or colorectal surgery
- •Ongoing anti-coagulant therapy (eg. NOACS, heparin, Warfarin)
- •Acute diverticulitis and diverticular abscess
- •Ischemic colitis
- •Colorectal cancer
- •Any physical handicap that prevents usage of product
- •Inability to use product or anyone to assist in its usage
- •Person not suitable for the investigation according to the investigator judgement
结局指标
主要结局
Patient satisfaction
时间窗: 4 weeks
Patient Reported Outcome - Overall patient satisfaction when performing low- volume trans-anal irrigation measured with a 5-graded scale \[0 = Not at all satisfied, 1 = Not satisfied, 2 = Neither satisfied nor unsatisfied, 3=Satisfied, 4 = Very satisfied\]
次要结局
- Ease of handling(4 weeks)
- Safety Outcome(4 weeks)
- Assessment of clinical benefit(4 weeks)