N/A N=11 Other

Clinical Investigation Exploring Two Ostomy Product Prototypes

Stoma Ileostomy

Bottom Line

View on ClinicalTrials.gov: NCT06237686 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcome: Primary: Primary Objective — 7; 4; 1; 4 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CP363 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Coloplast A/S
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Objective	7; 4; 1; 4; 2; 2	—

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.

Eligibility Criteria

Inclusion Criteria

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

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 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)
Participates in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol
Has any known allergies towards ingredients in the investigational device

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06237686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.