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Peristeen Light Explorative Clinical Investigation
Sponsor: Coloplast A/S
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.
Official title: An Explorative Clinical Investigation to Understand the Clinical Benefits of Peristeen Light
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-11-10
Completion Date
2026-08-01
Last Updated
2026-02-11
Healthy Volunteers
No
Interventions
Peristeen Light - trans anal irrigation system
Subjects naive to TAI will use Peristeen Light trans anal irrigation
Locations (1)
Århus University Hospital
Aarhus, Gotland, Denmark