NCT07146035

Feasibility of a Newly Developed Ostomy Prototype

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Despite the development of better stoma products, individuals with intestinal stomas can experience leakage problems, which negatively affect their quality of life. To overcome this, Coloplast are in the process of developing a leakage measurement device. Each participant will undergo five 24-hour test periods over three weeks, wearing the prototype around the stoma (Test) and on the opposite side (Control).

Conditions

• Stoma - Ileostomy

Interventions

Type	Name	Description
DEVICE	CP369 Feasibility of a newly developed ostomy prototype (only one intervention)	The study is an open-label, single-arm, comparative study, investigating the feasibility of the prototype in subjects with ileostomy. The study is comparing the prototype exposed only to sweat (abdominal side) with the prototype exposed to sweat and output (peristomal side). Meaning, subjects are their own control.

Timeline

• Start date: 2025-08-25
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

1 site across 1 country: Denmark