An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products
NCT ID: NCT02351817
Last Updated: 2016-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2015-02-28
2015-03-31
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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Baseline - Test A - Test B
Three period investigation. First each subject tests baseline product, then Test A and finally Test B.
Baseline product: the subject's usual product
Test A: A newly developed 1-piece, open ostomy appliance for collecting feces
Test B: A newly developed 1-piece, open ostomy appliance for collecting feces
Test A
Ostomy appliance
Test B
Ostomy appliance
Baseline
Ostomy appliance
Baseline - Test B - Test A
First each subject tests baseline product, then Test B and finally Test A.
Baseline product: the subject's usual product
Test A: A newly developed 1-piece, open ostomy appliance for collecting feces
Test B: A newly developed 1-piece, open ostomy appliance for collecting feces
Test A
Ostomy appliance
Test B
Ostomy appliance
Baseline
Ostomy appliance
Interventions
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Test A
Ostomy appliance
Test B
Ostomy appliance
Baseline
Ostomy appliance
Eligibility Criteria
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Inclusion Criteria
* Be at least 18 years of age and have full legal capacity
* Be able to handle the products her/himself
* Have an ileostomy with a diameter between 10 and 30 mm
* Willing to follow the product change schedule (one change per day)
* Have had their ostomy for at least three months
* Willing to use 1 piece open ostomy products during the test period
* Must be able to use a custom cut product
* Have intact skin
* Negative result of a pregnancy test for women of childbearing age
Exclusion Criteria
* 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.
* Is participating in other interventional clinical investigations or have previously participated in this investigation
* Have a loop ileostomy
* Known hypersensitivity towards any of the test products
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 Petersen Jakobsen, MD
Role: PRINCIPAL_INVESTIGATOR
Coloplast A/S
Locations
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Coloplast A/S
Humlebæk, , Denmark
Countries
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Other Identifiers
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CP256
Identifier Type: -
Identifier Source: org_study_id
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