Clinical Investigation Exploring Two Ostomy Product Prototypes

Not Applicable

Completed

• Conditions: Stoma Ileostomy
• Interventions: Device: CP363

• Registration Number: NCT06237686
• Lead Sponsor: Coloplast A/S

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-02
• Study Start: 2024-01-09
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-02-01
• Primary Completion: 2024-02-02
• Study Completion: 2024-02-02
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one-armed study	CP363	-

Primary Outcome Measures

Name	Time	Method
Primary objective	8 days	The primary objective is to investigate Test product A and B's ability to swell around the stoma. (assessed by photo/video)

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark