Peristeen Light Explorative Clinical Investigation

NCT07126327 | Recruiting

• 1 other identifier: CP378
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Faecal Incontinence; Constipation - Functional

Keywords

trans anal irrigation

Outcome Measures

Primary Outcomes (1)

• Bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit (V1) and End of Clinical Investigation Visit (V7).

  0 cm = worst possible bowel function and 10 cm = best possible bowel function.

  From enrollment to the end of treatment at week 12.

Study Arms (1)

Exploratory single-arm interventional investigation

EXPERIMENTAL

Prescription of Peristeen Light transanal irrigation system at enrolment to use for a 12 week test period

Device: Peristeen Light - trans anal irrigation system

Interventions

Peristeen Light - trans anal irrigation system DEVICE

Subjects naive to TAI will use Peristeen Light trans anal irrigation

Exploratory single-arm interventional investigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (2)

Århus University Hospital

Aarhus, Gotland, 8200, Denmark

RECRUITING

Montecatone Rehabillitation Institute S.p.A

Bologna, Italy

RECRUITING

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Central Study Contacts

Michel Briand de Crevecoeur

CONTACT

+4549111272; dkmibc@coloplast.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: August 17, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2025-08

Locations

DK (1); IT (1)