Assessment of New Ostomy Devices in Subjects Having an Ileostomy
NCT ID: NCT03427203
Last Updated: 2018-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2018-01-09
2018-04-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Arm 1
The subjects test the products in the following order
SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3
SenSura Mio
SenSura Mio is a marked ostomy device which is used as the comparator in this study
Coloplast Ostomy device 1
Coloplast Ostomy device 1 a newly developed ostomy device
Coloplast Ostomy device
Coloplast Ostomy device 2 a newly developed ostomy device
Coloplast Ostomy device 3
Coloplast Ostomy device 3 a newly developed ostomy device
Arm 2
The subjects test the products in the following order
SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2
SenSura Mio
SenSura Mio is a marked ostomy device which is used as the comparator in this study
Coloplast Ostomy device 1
Coloplast Ostomy device 1 a newly developed ostomy device
Coloplast Ostomy device
Coloplast Ostomy device 2 a newly developed ostomy device
Coloplast Ostomy device 3
Coloplast Ostomy device 3 a newly developed ostomy device
Interventions
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SenSura Mio
SenSura Mio is a marked ostomy device which is used as the comparator in this study
Coloplast Ostomy device 1
Coloplast Ostomy device 1 a newly developed ostomy device
Coloplast Ostomy device
Coloplast Ostomy device 2 a newly developed ostomy device
Coloplast Ostomy device 3
Coloplast Ostomy device 3 a newly developed ostomy device
Eligibility Criteria
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Inclusion Criteria
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy for at least 3 months
4. Must be able to use custom cut product
5. Can use a product with max cut size 45 mm
6. Self-reported problems with leakage (3 x within 14 days)
7. Get a negative result of a pregnancy test for women of childbearing age (only DK)
Exclusion Criteria
2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
3. Are pregnant or breastfeeding
5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
6. Have known hypersensitivity towards any of the products used in the investigation
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Birte P Jakobsen, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Director
Locations
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Coloplast A/S
Humlebæk, , Denmark
CCBR Vejle
Vejle, , Denmark
QPS Netherlands
Groningen, , Netherlands
Countries
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Other Identifiers
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CP264
Identifier Type: -
Identifier Source: org_study_id
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