Actively Recruiting
An Explorative Clinical Investigation to Understand the Clinical Benefits of Peristeen Light
Led by Coloplast A/S · Updated on 2026-04-14
60
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the clinical benefits of using the Peristeen Light transanal irrigation system in adults who have faecal incontinence, chronic constipation, or require time-consuming bowel management. The study focuses on evaluating changes in bowel function over a 12-week period using this device. It is an exploratory clinical investigation designed to assess bowel function improvements in these patients. Participants will receive a prescription for the Peristeen Light transanal irrigation system at enrollment and will use it for a 12-week test period. This device is intended to help manage bowel function through low-volume transanal irrigation. The study involves a single treatment group where all participants use the device during the study period. During the study, participants will have their bowel function measured using a 10 cm Visual Analog Scale (VAS) at the beginning (Baseline Visit) and at the end of the 12-week treatment period (End of Clinical Investigation Visit). Researchers will monitor adherence and collect data on bowel symptoms, with assessments supported by smartphone use. The total participation duration for each participant is approximately 12 weeks.
CONDITIONS
Brief Title
Peristeen Light Explorative Clinical Investigation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has given written informed consent
- Is at least 18 years old
- Has full legal capacity
- Is able and willing to follow study procedures during the clinical investigation
- Has access to and can use a smartphone
- Has constipation and/or faecal incontinence symptoms based on specific criteria during the last 3 months
- Is assessed to need low-volume transanal irrigation at least every other day
You will not qualify if you...
- Is participating in any other clinical investigation
- Has previously completed this investigation
- Is a former or current user of transanal irrigation
- Has known hypersensitivity to the device
- Is pregnant
- Has known anal stenosis
- Has active or recurrent colorectal cancer
- Has had 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
- Has chronic diarrhea
- Has bowel dysfunction due to neurogenic disorders
- Needs high-volume transanal irrigation as assessed by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants use the Peristeen Light trans anal irrigation system as prescribed for managing bowel function.
Baseline visit and end of treatment visit
Trial Site Locations
Total: 2 locations
1
Århus University Hospital
Aarhus, Gotland, Denmark, 8200
Actively Recruiting
2
Montecatone Rehabillitation Institute S.p.A
Bologna, Italy
Actively Recruiting
Research Team
M
Michel Briand de Crevecoeur
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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