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Feasibility of a Newly Developed Ostomy Prototype
Sponsor: Coloplast A/S
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).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2025-08-25
Completion Date
2025-09-30
Last Updated
2025-08-28
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Coloplast, UserLab
Humlebæk, Denmark