An Explorative Clinical Investigation to Understand the Clinical Benefits of Peristeen Light
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit (V1) and End of Clinical Investigation Visit (V7).
研究概览
简要总结
The goal of this exploratory clinical investigation is to understand the clinical benefits of Peristeen Light in adult patients with faecal incontinence, chronic constipation and/or time-consuming bowel management procedures.
The primary objective is to evaluate changes in bowel-function when using Peristeen Light. Participants will use Peristeen Light for 12 weeks test period.
详细描述
The goal of this exploratory clinical investigation is to understand the clinical benefits of Peristeen Light in adult patients with faecal incontinence, chronic constipation and/or time-consuming bowel management procedures.
The primary endpoint is bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit and end of Clinical Investigation visit.
Participants will use Peristeen Light for 12 weeks test period.
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
- •Has given written informed consent
- •Is at least 18 years old
- •Has full legal capacity
- •Is able (assessed by investigator) and willing to adhere to clinical investigational procedures during clinical investigation-al duration
- •Has access to and is able to use a smartphone
- •Has constipation and/or faecal incontinence based on one or more of the following symptoms during the last 3 month: Straining in more than 25% of defecations, lumpy stools (Bristol Stool Type 1 and 2) in more than 25% of defecations, sensation of incomplete evacuation in more than 25% of defecations, sensation of anorectal obstruction/blockage in more than 25% of defecations, need to use manual maneuvers to facilitate defecation in more than 25% of defecations, fewer than three spontaneous bowel movements per week, loose stools are rarely present without use of laxatives, recurrent uncontrolled passage of faecal material (other words to describe this could be: Soiling, leak-age, passive faecal incontinence of flatus, mucus and/or stool)
- •Is assessed (by investigator) to have a need for low-volume TAI minimum every other day
排除标准
- •Is participating in any other clinical investigation during this investigation
- •Has previously completed this investigation
- •Is former or current user of transanal irrigation (low- and high volume)
- •Has known hypersensitivity towards the device used in the investigation
- •Is pregnant
- •Has known anal stenosis
- •Has active/recurrent colorectal cancer
- •Has had anastomotic colorectal surgery within the last 3 months
- •Has ischaemic colitis
- •Has active inflammatory bowel disease
- •Has acute diverticulitis or diverticular abscess
- •Has medicine induced constipation (e.g. due to opioids)
- •Has chronic diarrhea
- •Has bowel dysfunction due to neurogenic disorder(s)
- •Is in need of high-volume TAI (as estimated by investigator)
研究组 & 干预措施
Exploratory single-arm interventional investigation
Prescription of Peristeen Light transanal irrigation system at enrolment to use for a 12 week test period
干预措施: Peristeen Light - trans anal irrigation system (Device)
结局指标
主要结局
Bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit (V1) and End of Clinical Investigation Visit (V7).
时间窗: From enrollment to the end of treatment at week 12.
0 cm = worst possible bowel function and 10 cm = best possible bowel function.
次要结局
未报告次要终点