Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Questionnaire Measuring Subjects' Satisfaction of Navina Smart
研究概览
简要总结
This study is designed as an open, prospective, single arm, multicenter study in order to investigate patient satisfaction, perception and compliance for the novel Navina Smart, a transanal irrigation (TAI) system. Approximately 30 male and female subjects who are currently practicing TAI, will be followed during a 4-week period of use of Navina Smart. Observational data on satisfaction, perception, compliance, bowel regimen, TAI therapy and TAI frequency will be collected via patient reported outcome (PRO) questionnaires.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Males and females, aged 18 years and over
- •Practice TAI since at least 2 months and at least two times per week
- •Able to read and fill out a paper PRO questionnaire as judged by the principal investigator or a sub-investigator
排除标准
- •Any confirmed or suspected diagnosis of anal or rectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions
- •Untreated rectal impaction
- •Any radiotherapy to the pelvis
- •Any current treatment with anticoagulants (not including aspirin or clopidogrel)
- •Any current treatment with long-term systemic steroid medication (not including inhalation agents and/ or local topical treatment)
- •Any prior rectal or colonic surgery (not including anal procedures >3 months ago, e.g. haemorrhoid excision)
- •Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks
- •Overt or planned pregnancy
- •Ongoing symptomatic urinary tract infection as judged by the principal investigator or a sub-investigator
- •Diagnosed psychiatric illness, considered as unstable by the principal investigator or a sub-investigator
- •Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
- •Previous enrolment in the present study
- •Participation in another clinical study within the last 30 days that may interfere with the present study
结局指标
主要结局
Questionnaire Measuring Subjects' Satisfaction of Navina Smart
时间窗: 4 weeks
PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of satisfaction when using the study device. Satisfaction was assessed in a range of ways through different questions to be answered by each subject. For example each subject received the question "If possible, would you consider continuing using the Navina Smart system?"
Questionnaire Measuring Subjects' Perception of Navina Smart
时间窗: 4 weeks
PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of perception when using the study device. For example, each subject answered the following question regarding perception: "How satisfied are you with the Navina Smart System?"
Questionnaire Measuring Subjects' Compliance of Navina Smart
时间窗: 4 weeks
PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's compliance towards the study device. For example, each subject answered the following question "Did you use the Navina Smart system for 4 weeks?"
次要结局
- Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart(4 weeks)