Clinical Investigation Exploring Two Ostomy Product Prototypes

NCT06237686 | Completed Results

• 1 other identifier: CP363
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Two ostomy product prototypes (Test product A and B) will be tested in this investigation. All subjects will test both Test product A and B, with a minimum of 7 days apart. In total, each subject will be enrolled in the investigation for 8 days +3 days.

Conditions

Stoma Ileostomy

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  Test product A and B's ability to swell around the stoma (assessed by photo/video)

  4 hours

Study Arms (1)

one-armed study

EXPERIMENTAL

Device: CP363

Interventions

CP363 DEVICE

All subjects will test both Test product A and B, with a minimum of 7 days apart. In total, each subject will be enrolled in the investigation for 8 days +3 days.

one-armed study

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 informed consent
• Is at least 18 years of age and has full legal capacity
• Has had an ileostomy for more than 3 months
• Has suitable peristomal skin area (assessed by investigator)
• Is currently using flat SenSura Mio 1-piece or 2-piece
• Has used flat SenSura Mio 1-piece or 2-piece for at least 14 days
• Has a stoma size less than 45mm in diameter

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 indications other 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 or systemic steroid (tablet/injection) treatment
• Is pregnant or breastfeeding
• Has dermatological problems in the peristomal area (assessed by investigator)
• Has any known allergies towards ingredients in the investigational device

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Results Point of Contact

• Title: Principal Investigator: Søren Meisner, MD
• Organization: Medical Consultant

sm_meisner@hotmail.com

+4520117378

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: February 1, 2024
• Study Start: January 9, 2024
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)