NCT07316530

Clinical Investigation Exploring a Newly Developed Ostomy Baseplate.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, which affect their quality of life negatively. Among the main reasons for developing PSCs are that the peristomal skin is exposed to stomal output either due to leakage of output under the baseplate and/or imperfect cutting of the hole in the baseplate, and incorrect application creating a gap between the hole in the baseplate and the stoma. To seal this gap, Coloplast has developed a new ostomy baseplate and the aim of the investigation is to explore the investigational device 's ability to help protect the peristomal skin.

Conditions

• Stoma Ileostomy

Interventions

Type	Name	Description
DEVICE	CP381	All subjects will test the investigational device and the comparator for 6 hours during two different test days, with at least 14 days between the test days. Before the application of the investigational device as well as comparator, the stoma will be measured by the test personal and the baseplate will be pre-cut too big, leaving an approximately 5 mm distance from the edge of the hole in the baseplate to the stoma. The baseplates will be unique to each subject.

Timeline

• Start date: 2025-11-03
• Primary completion: 2026-01-09
• Completion: 2026-01-09
• First posted: 2026-01-05
• Last updated: 2026-01-23

Locations

1 site across 1 country: Denmark