NCT07126327

Peristeen Light Explorative Clinical Investigation

An Explorative Clinical Investigation to Understand the Clinical Benefits of Peristeen Light

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 endpoint is bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit and end of Clinical Investigation visit. Participants will use Peristeen Light for 12 weeks test period.

Conditions

• Faecal Incontinence
• Constipation - Functional

Interventions

Type	Name	Description
DEVICE	Peristeen Light - trans anal irrigation system	Subjects naive to TAI will use Peristeen Light trans anal irrigation

Timeline

• Start date: 2025-11-10
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-08-17
• Last updated: 2026-04-14

Locations

2 sites across 2 countries: Denmark, Italy