Status:
TERMINATED
Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care
Lead Sponsor:
Coloplast A/S
Conditions:
Leakage
Skin Condition
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates. ...
Eligibility Criteria
Inclusion
- Have given written Informed Consent
- Is at least 18 years old
- Has the mental capacity to understand the study guidelines and questionnaires
- Has had their ileostomy for at least 3 months
- Has an ileostomy with a diameter between 19-40 mm
- Is currently using a flat 2-piece product with with mechanical coupling
- Is able to change the base plate by themselves or with help from a caregiver (e.g. spouse)
- Has experienced leakage under the base plate at least once a week over the last 2 weeks
Exclusion
- Is pregnant or breast-feeding
- Currently receiving or has within the past 2 months received radio- and/or chemotherapy
- Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted)
- Is currently using a convex base plate
- Participating in other clinical studies or has previously participated in this study
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01517178
Start Date
May 1 2011
End Date
June 1 2011
Last Update
March 13 2015
Active Locations (11)
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1
Sygehus Sønderjylland i Aabenraa
Aabenraa, Denmark, 6200
2
Bispebjerg Hospital
Copenhagen, Denmark, 2400
3
Hvidovre Hospital
Hvidovre, Denmark, 2650
4
Odense Universitetshospital
Odense, Denmark, 5000