An Uncontrolled, Prospective, Multicenter, Post-market Clinical Investigation to Confirm the Performance and Safety of Navina Mini, a New CE-marked Low-volume Trans-anal Irrigation (TAI) Device in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Overall patient satisfaction
研究概览
简要总结
The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents.
详细描述
This is an uncontrolled, prospective, multicentre post-market clinical follow-up investigation that will enroll male and female children /adolescents with a need for low-volume transanal irrigation (TAI) as judged by the investigator or designee.
A total of 27 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. Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four (4) to six (6) weeks.
The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm device safety when used in children and adolescents.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Male and female children/adolescents between 3 and 17 years of age at the time of inclusion
- •Diagnosis of at least one of the following:
- •functional constipation not well treated with oral laxatives
- •functional fecal incontinence, either retentive or non-retentive (FNRFI: Functional Non-Retentive Fecal Incontinence) not well treated with oral laxatives
- •neurogenic bowel dysfunction due to spinal abnormalities and/or spinal cord injury or cerebral palsy
- •patient with sequelae of anorectal malformations to Hirschsprung disease
- •Fecal Incontinence (FI) due to iatrogenic injury including tumor surgery sequelae
- •Symptom duration of > 3 months
- •Subject and/or their legally designated representative can communicate in written and oral Swedish language
排除标准
- •Children/adolescents previously treated with, or currently in need of, high volume TAI, i.e., volume > 250 ml
- •Confirmed pregnancy at the time of enrollment
- •Participating in another clinical investigation interfering with this investigation
- •Subjects with an 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 (i.e., NOACS, heparin, warfarin)
- •Ischemic colitis
- •Active anal fissure
- •Inability to use the product or anyone to assist in its usage (hand function assessment)
- •Person not suitable for the investigation according to the investigator's judgment
结局指标
主要结局
Overall patient satisfaction
时间窗: up to 6 weeks
Overall patient satisfaction measured with a 5-graded assessment scale (Patient Reported Outcome (PRO) via Wellspect Questionnaire: 0 = Not at all satisfied, 1 = Not satisfied, 2 = Neither satisfied nor unsatisfied, 3=Satisfied, 4 = Very satisfied)
次要结局
- Episodes of fecal incontinence(up to 6 weeks)
- Perception of handling of the device(up to 6 weeks)
- Safety outcome(up to 6 weeks)
- Incomplete bowel emptying(up to 6 weeks)
- Level of independence(up to 6 weeks)