NCT02979808已完成不适用
An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 22
- 主要终点
- Change in neurogenic bowel disfunction symptoms.
研究概览
简要总结
This study is designed as an open, prospective, non-controlled, qualitative, multicentre study of a novel transanal irrigation system performed in a population of 150 subjects suffering from spinal cord injury and confirmed neurological bowel dysfunction. The study is expected to last for a total of 1 year (treatment period) with a planned 12- month recruitment period and three scheduled site visits.
详细描述
This study will be conducted in multiple countries, all outside of the United States. The study is approved by oversight authorities in the United Kingdom, Germany, Spain, Sweden, Denmark, Norway, France, and Italy
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.
- •Male or female aged 18 years or older.
- •Patient with previously confirmed chronic spinal cord injury, either:
- •Traumatic; at any level and any completeness of injury and ASIA grade classification, or
- •Non-traumatic; due to infection, inflammation (i.e.; transverse myelitis or ischaemic myelitis), compromised blood supply, a post-ischemic state, etc.
- •At least 3 months post spinal cord injury at time of consent.
- •NBD score ≥10, confirmed at Baseline .
- •Only TAI treatment - naïve patient (not having previously used any particular transanal irrigation system, e.g. Peristeen®).
- •Confirmed NBD refractory to conservative therapy and judged eligible for transanal irrigation as per standardised treatment pathway
- •Able to handle smartphone/tablet.
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).
- •Current use of prokinetics.
- •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 UTI as judged by investigator.
- •Diagnosed psychiatric illness, considered as unstable by the investigator.
- •Diagnosed with MS.
- •Involvement in the planning and conduct of the study (applies to both WHC staff and staff at the study site).
- •Previous enrolment in the present study.
- •Simultaneous participation in another clinical study that may interfere with the present study.
结局指标
主要结局
Change in neurogenic bowel disfunction symptoms.
时间窗: 3 months
1. The primary objective of this study is to evaluate change in neurogenic bowel dysfunction symptoms between baseline and 3 months use of the Navina™ Smart system, as measured by a patient friendly version of the validated instrument NBD Score.
次要结局
- Change of QoL status(Baseline, 3-months, 12-months)
- Patient satisfaction assessed through patient reported outcome (PRO) variables.(3-months and 12-months)
- Frequency of urinary tract infection (UTI).(3-months and 12-months)
- Health economic analysis utilizing QoL data.(Baseline, 3-months, and 12-months.)
- Product use compliance.(3-months, 6-months, 9-months, and 12-months)
- Incidence of adverse events, serious adverse events, and adverse device effects.(3-months, 6-months, 9-months, 12-months)
- NBD symptoms(6-months, 9-months, 12-months)
- Health economic analysis utilizing patient reported outcome (PRO) variables.(Baseline, 3-months, and 12-months.)
- Thematic analysis of interview data.(Baseline, 3-months, and 12-months (or at end of treatment period).)
研究者
研究点 (22)
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