Clinical Investigation Exploring a Newly Developed Ostomy Baseplate

NCT07376421 | Completed

• 1 other identifier: CP383
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Maximum itching scale 0-10)

  Itching score (weekly max at steady state\* scale 0-10). \* To account for a possible carry-over effect, the steady state period of the treatment period begins after two weeks of investigational device or comparator use. It is anticipated that the skin will have adapted to the new device after two weeks.

  8 weeks

Study Arms (2)

Investigational device

EXPERIMENTAL

4 weeks treatment with investigational device

Device: Incestigational device

Comparator

ACTIVE COMPARATOR

4 weeks treatment with investigational device

Device: Comparator

Interventions

Comparator DEVICE

4 weeks treatment with comparator

Comparator

Incestigational device DEVICE

4 weeks treatment with investigational device

Investigational device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has given written consent
• Is at least 18 years of age
• Has full legal capacity
• Has an ileostomy with consistent liquid fecal output (6-7 Bristol scale).
• Has had the stoma for at least 90 days.
• Has a stoma size less than 40mm in diameter
• Has experienced leakage under the baseplate at least three times within the last 14 days.
• Leakage defined as output/seeping under the baseplate (see Appendix A)
• 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)
• Is able to handle the electronic diary (questionnaire/photo) themselves. If needed, a trained spouse or caretaker is allowed to assist.
• Is able to handle (apply, remove, etc.) the investigational devices themselves.
• Understands that any supporting products under the baseplate are not permissible during the investigation (except for adhesive removers) and is willing to not use these during the investigation.
• Is willing and suitable (determined by the Principal Investigator or designee) to use a flat 2-piece device during the investigation.
• Is willing to change the baseplate at least every third/fourth day during the investigation.

You may not qualify if:

• 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 treatment.
• Is breastfeeding.
• Is pregnant based on urine pregnancy test.
• Has known hypersensitivity towards any of the investigational devices used in the investigation.
• Has a complicated stoma at baseline, as assessed by investigator (e.g., dehiscence/prolapse/hernia).
• Daily use of analgesics, antihistamine or steroid treatment

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 29, 2026
• Study Start: January 24, 2026
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-01

Locations

DK (1)