A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
Status
Completed
Conditions
Stoma Site Leakage
Treatments
Device: Test product A
Device: Test product B
Device: Comparator
Details and patient eligibility
About
An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
Full description
The test products are non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
Enrollment
12 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Has given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had a stoma for more than ½ year
- Have intact skin on the area used in the study (Assessed by investigator, see Appendix 1).
- Willing to change baseplate every second day or less frequent
- Willing to avoid using Concave baseplate during the study.
- Willing to avoid the use of barrier creams or similar that affect the skin/adhesive interface under the tape.
Exclusion criteria
- Currently receiving or have within the past 2 months received radio-and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet(injection) treatment
- Is pregnant or breastfeeding
- Having dermatological problems in the peristomal area (assessed by investigator)
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
12 participants in 3 patient groups
Test product A new adhesive material
Experimental group
Description:
The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.
Treatment:
Device: Comparator
Device: Test product A
Device: Test product B
Test product B new adhesion material
Experimental group
Description:
The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.
Treatment:
Device: Comparator
Device: Test product A
Device: Test product B
Comparator
Active Comparator group
Description:
The comparator product is Brava Elastic tape which is already on the market and will be used within the in-tended use in this clinical investigation.
Treatment:
Device: Comparator
Device: Test product A
Device: Test product B
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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