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Recruiting NCT07126327

Peristeen Light Explorative Clinical Investigation

Trial Parameters

Condition Faecal Incontinence
Sponsor Coloplast A/S
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-10
Completion 2026-08-01
Interventions
Peristeen Light - trans anal irrigation system

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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 faec

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