Peristeen Light Explorative Clinical Investigation

Официальное название

An Explorative Clinical Investigation to Understand the Clinical Benefits of Peristeen Light

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Peristeen Light - trans anal irrigation system
  Subjects naive to TAI will use Peristeen Light trans anal irrigation

Первичные конечные точки

• Bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit (V1) and End of Clinical Investigation Visit (V7). [Срок оценки: From enrollment to the end of treatment at week 12.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Århus University Hospital — Aarhus

Италия · 1 центр

• Montecatone Rehabillitation Institute S.p.A — Bologna

Идентификаторы

NCT: NCT07126327 · CP378

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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