Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
NCT ID: NCT01272869
Last Updated: 2012-12-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2011-01-31
2011-03-31
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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Sensura
SenSura is the reference product and the product is already commercially available
SenSura
The ostomy bag filter will be tested for a period of 14 days
Morfeus
The test product is the product with the proposed new filter (Morfeus)
Morfeus
The new ostomy bag filter will be tested for a period of 14 days
Interventions
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SenSura
The ostomy bag filter will be tested for a period of 14 days
Morfeus
The new ostomy bag filter will be tested for a period of 14 days
Eligibility Criteria
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Inclusion Criteria
* Have given written informed consent.
* Be able to fill in the Case Report Form.
* Be ileostomy operated and have had a stoma for at least 6 months.
* Experience ballooning at least once per week.
* Be able to manage the bags themselves (application, removal).
* Be able to use a flat base plate.
* Have a stoma with a diameter less than 60 mm
Exclusion Criteria
* Currently suffer from peristomal skin problems (i.e. bleeding or broken skin).
* Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
* Pregnant or breastfeeding.
* Participate in other test at the same time.
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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Daniel Carter, MSc
Role: STUDY_CHAIR
Coloplast A/S
Locations
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Coloplast A/S
Humlebæk, , Denmark
Countries
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Other Identifiers
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CP211OC
Identifier Type: -
Identifier Source: org_study_id