Actively Recruiting
Peristeen Light Explorative Clinical Investigation
Led by Coloplast A/S · Updated on 2026-04-14
60
Participants Needed
2
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 clinical investigation procedures during the study
- Has access to and is able to use a smartphone
- Has constipation and/or faecal incontinence with symptoms during the last 3 months such as straining in more than 25% of bowel movements, lumpy stools (Bristol Stool Type 1 and 2) in more than 25% of bowel movements, sensation of incomplete evacuation in more than 25% of bowel movements, sensation of anorectal blockage in more than 25% of bowel movements, need to use manual maneuvers in more than 25% of bowel movements, fewer than three spontaneous bowel movements per week, rare loose stools without laxatives, or recurrent uncontrolled passage of faecal material
- Is assessed by investigator to need low-volume trans anal irrigation at least every other day
You will not qualify if you...
- Is participating in any other clinical investigation during this study
- Has previously completed this investigation
- Is a former or current user of trans anal irrigation (low- or high-volume)
- Has known allergy to the device used
- Is pregnant
- Has known anal stenosis
- Has active or 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 constipation caused by medication such as opioids
- Has chronic diarrhea
- Has bowel problems due to neurogenic disorders
- Needs high-volume trans anal irrigation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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