Stoma Ileostomy
Conditions
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.
Interventions
DEVICECP363
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.
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | 4 hours | Test product A and B's ability to swell around the stoma (assessed by photo/video) |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| One-armed Study 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | One-armed Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 4 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Age, Continuous | 59.1 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 10 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
| Type of stoma Ileostomy | 10 Participants | — |
| Type of stoma Other | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 1 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Primary Objective
Test product A and B's ability to swell around the stoma (assessed by photo/video)
Time frame: 4 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| One-armed Study | Primary Objective | Product A. Completely covered in the swelling area | 7 Participants |
| One-armed Study | Primary Objective | Product B. Completely covered in the swelling area | 4 Participants |
| One-armed Study | Primary Objective | Product A. Partly covered in the swelling area | 1 Participants |
| One-armed Study | Primary Objective | Product B. Partly covered in the swelling area | 4 Participants |
| One-armed Study | Primary Objective | Product A. Not covered at all in the swelling area | 2 Participants |
| One-armed Study | Primary Objective | Product B. Not covered at all in the swelling area | 2 Participants |
| One-armed Study | Primary Objective | Product B. No uniform circular swelling | 2 Participants |
| One-armed Study | Primary Objective | Product A. Uniform circular swelling | 9 Participants |
| One-armed Study | Primary Objective | Product B. Uniform circular swelling | 8 Participants |
| One-armed Study | Primary Objective | Product A. No uniform circular swelling | 1 Participants |