Clinical Investigation Exploring a Newly Developed Ostomy Baseplate.

NCT ID: NCT07316530

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-03
• Study Completion Date: 2026-01-09

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Investigational device

1 day treatment with investigational device

Group Type: EXPERIMENTAL

CP381

Intervention Type: DEVICE

All subjects will test the investigational device and the comparator for 6 hours during two different test days, with at least 14 days between the test days.

Before the application of the investigational device as well as comparator, the stoma will be measured by the test personal and the baseplate will be pre-cut too big, leaving an approximately 5 mm distance from the edge of the hole in the baseplate to the stoma. The baseplates will be unique to each subject.

Comparator

1 day treatment with comparator

Group Type: ACTIVE_COMPARATOR

CP381

Intervention Type: DEVICE

All subjects will test the investigational device and the comparator for 6 hours during two different test days, with at least 14 days between the test days.

Before the application of the investigational device as well as comparator, the stoma will be measured by the test personal and the baseplate will be pre-cut too big, leaving an approximately 5 mm distance from the edge of the hole in the baseplate to the stoma. The baseplates will be unique to each subject.

Interventions

CP381

All subjects will test the investigational device and the comparator for 6 hours during two different test days, with at least 14 days between the test days.

Before the application of the investigational device as well as comparator, the stoma will be measured by the test personal and the baseplate will be pre-cut too big, leaving an approximately 5 mm distance from the edge of the hole in the baseplate to the stoma. The baseplates will be unique to each subject.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Has given written informed consent
• Is at least 18 years old
• Has full legal capacity
• Has an ileostomy with consistent liquid faecal output (6-7 Bristol scale).
• Has used flat SenSura Mio 1-piece or 2-piece for at least 14 days before the inclusion.
• Has had the stoma for at least 90 days
• Has a stoma size less than 45mm in diameter
• Has experienced symptoms of peristomal skin complications such as itching, burning, or pain in the peristomal area within the last 14 days
• Has suitable peristomal skin area (assessed by investigator) to participate in investigation
• Is willing to refrain from analgesics within 24 hours before the test days
• Is willing to refrain from antihistamine within 96 hours before the test days
• Is willing to refrain from steroid treatment within 24 hours before the test days

Exclusion Criteria

• Is currently receiving or have within the past 60 days received radio-and/or chemotherapy.
• low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for other indications than cancer.
• Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray.
• Is breastfeeding
• Is pregnant based on urine pregnancy test.
• Has known hypersensitivity towards any of the devices used in the investigation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Thomas Krarup Simonsen

Humlebæk, , Denmark

Countries

Denmark

Other Identifiers

CP381

Identifier Type: -

Identifier Source: org_study_id