Clinical Trial

Clinical Investigation Exploring a Newly Developed Ostomy Baseplate

Completed
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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.
Protocol Amendment History 1 change
critical Trial completed 2026-05-02
Trial Details
NCT Number NCT07376421
Lead Sponsor Coloplast A/S
Conditions Stoma Ileostomy
Enrollment 20 participants
Start Date 2026-01-24
Primary Completion 2026-04-09 (estimated)
Study Completion 2026-04-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-01