Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
NCT ID: NCT01994902
Last Updated: 2016-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
129 participants
INTERVENTIONAL
2013-11-30
2014-06-30
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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First Coloplast test product
The subjects test:
test period 1: Coloplast test product test period 2: SenSura Convex Light
Coloplast test product
The Coloplast test product is a newly developed ostomy appliance
SenSura Convex Light
The comparator product is SenSura Convex Light, which is CE-marked and commercially available.
First SenSura Convex Light
The subjects test:
test period 1: SenSura Convex Light test period 2: Coloplast test product
Coloplast test product
The Coloplast test product is a newly developed ostomy appliance
SenSura Convex Light
The comparator product is SenSura Convex Light, which is CE-marked and commercially available.
Interventions
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Coloplast test product
The Coloplast test product is a newly developed ostomy appliance
SenSura Convex Light
The comparator product is SenSura Convex Light, which is CE-marked and commercially available.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has had an ileostomy for at least 3 months.
3. Has used a convex ostomy product for the last month.
4. Has given signed informed consent.
5. Has experienced seeping under the baseplate at least three times during the last two weeks.
6. Currently using a SenSura Convex product with midi, maxi or magnum bags.
7. Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
8. Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.
Exclusion Criteria
2. Are pregnant or breastfeeding.
3. Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
4. Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
5. Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
6. Are currently participating in another clinical intervention study or have previously participated in this one.
7. Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.
8. Has known hypersensitivity toward the test product.
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
Role: STUDY_DIRECTOR
Coloplast A/S
Locations
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TFS
Søborg, , Denmark
Hopital du bocage
Dijon, , France
Hopital Robert Boulin
Libourne, , France
Hopital Claude Huriez
Lille, , France
Hopital Nord
Marseille, , France
Hopital Cochin
Paris, , France
Hopital Tenon
Paris, , France
Hopital de Haut Levêque
Pessac, , France
CHRU La Milétrie
Poitiers, , France
BB medica medizinisches
Aachen, , Germany
Sanitätshause reinhold hilscher e.K.
Augsburg, , Germany
Patientenberatung Strack e.K.
Bad Staffelstein, , Germany
Pro-samed Santitätshaus
Berlin, , Germany
SIEWA coloplast Homecare
Burgdorf, Hanover, , Germany
SIEWA Coloplast Homecare
Freising, , Germany
SIEWA Coloplast homecare
Leinfelden-Echterdingen, , Germany
Schürmaier GmbH &Co
Leipzig, , Germany
Sanitätshaus Fürst GmbH
Passau, , Germany
SIEWA Coloplast Homecare
Saulgrub, , Germany
Sanitäts- und gesundheitshaus Carqueville GmbH
Töppeln, , Germany
Alippi GmbH
Zwickau, , Germany
Sykpleierklinikken
Larvik, , Norway
Pilgrim Hospital
Boston, , United Kingdom
Addenbrookes
Cambridge, , United Kingdom
Cheltenham General Hospital
Gloucestershire, , United Kingdom
Lincon Country hospital
Lincoln, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Kettering General hospital
Northamptonshire, , United Kingdom
west Suffolk Hospital
Suffolk, , United Kingdom
Countries
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Other Identifiers
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CP232
Identifier Type: -
Identifier Source: org_study_id
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