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Clinical Investigation Exploring a Newly Developed Ostomy Baseplate

NCT07376421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-01

No results posted yet for this study

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

DEVICE

Incestigational device

4 weeks treatment with investigational device

DEVICE

Comparator

4 weeks treatment with comparator

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-24
Primary Completion
2026-04-09
Completion
2026-04-09

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07376421 on ClinicalTrials.gov