Peristeen Light Explorative Clinical Investigation
NCT07126327 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-04-14
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
Interventions
- DEVICE
-
Peristeen Light - trans anal irrigation system
Subjects naive to TAI will use Peristeen Light trans anal irrigation
Sponsors & Collaborators
-
Coloplast A/S
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-10
- Primary Completion
- 2026-08-01
- Completion
- 2026-08-01
Countries
- Denmark
- Italy
Study Locations
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