NCT07376421

Clinical Investigation Exploring a Newly Developed Ostomy Baseplate

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• 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	Incestigational device	4 weeks treatment with investigational device
DEVICE	Comparator	4 weeks treatment with comparator

Timeline

• Start date: 2026-01-24
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2026-01-29
• Last updated: 2026-03-18

Locations

1 site across 1 country: Denmark