Clinical Investigation Exploring Two Ostomy Product Prototypes

Coloplast

Status: Completed

Conditions: Stoma Ileostomy

Treatments: Device: CP363

Study type: Interventional

Funder types: Industry

Identifiers

NCT06237686

CP363

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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)
2. 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
3. Is pregnant or breastfeeding
4. Has dermatological problems in the peristomal area (assessed by investigator)
5. 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
6. Has any known allergies towards ingredients in the investigational device

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

one-armed study

Experimental group

Treatment:

Device: CP363