Clinical Investigation Exploring Two Ostomy Product Prototypes

Stoma Ileostomy Clinical Trial

Official title:

Clinical Investigation Exploring Two Ostomy Product Prototypes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06237686
• Other study ID #: CP363
• Status: Completed
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: February 2, 2024

Study information

• Verified date: January 2024
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2, 2024
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stoma Ileostomy

Intervention

Device:
• CP363
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.

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebæk

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary objective	The primary objective is to investigate Test product A and B's ability to swell around the stoma. (assessed by photo/video)	8 days