Status:
COMPLETED
Comparison of Two Urostomy Bags (2-piece).
Lead Sponsor:
Coloplast A/S
Conditions:
Urostomy Patent
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.
Detailed Description
The 2-piece product is a part of a new product family, under the brand name SenSura. The aim of this investigation is to see how the urology product is perceived and how it performs against another 2-...
Eligibility Criteria
Inclusion
- Be at least 18 years old,
- Be able to complete a written consent form
- Be able to fill in the Case Report Form
- Have a urostomy with a diameter of 33 mm. or less.
- Have had the urostomy for 3 months or more.
- Use a 2-piece convex (or convex light) normally.
- Be able to use SenSura URO 2-piece product
- Be able to use ConvaTec, 2-piece product
- Be able to handle the product themselves (application, removal and emptying),
Exclusion
- In order to be enrolled in the clinical investigation, the subjects must not:
- Need to use an ostomy belt
- Be currently suffering from any dermatological problems, needing special treatment, on the peristomal skin
- Being treated with chemo- or radiation therapy,
- Be hospitalized during study enrollment, or have a hospitalization or significant surgery planned during the 4-week study period, or
- Be pregnant or breast-feeding.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00761748
Start Date
September 1 2008
End Date
February 1 2009
Last Update
January 1 2013
Active Locations (1)
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1
Visé Mitteldeutschland GmbH
Magdeburg, Germany, 39114