Visé Mitteldeutschland GmbH
Magdeburg, 39114, Germany
Completed
NCT Number: NCT00761748
Comparison of Two Urostomy Bags (2-piece).
Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
About this study
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-piece product from ConvaTec. The device 'ConvaTec 2-piece combihesive Natura' is selected as the comparative product because of its similarity to SenSura 2-piece product.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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.
Treatment and study plan
Convatec Uro 2-piece
DeviceSpecific name of the device: 'Combihesive Natura® with a Durahesive Convex-It® base plate, 45 mm coupling, moldable (13-22 and 22-33 mm) hole size with boarder tape'.
The subjects are asked to test each of the two products for 21 days plus/minus 3 days in a randomised order and in accordance with their normal frequency of change and normal use pattern. The duration of the clinical investigation should be enough time to identify any difference in user-preference. If the subject is in the middle of testing an urostomy base plate when the test period is turning into the next period, the urostomy base plate can be worn until it needs to be changed. It is not possible to blind the investigation as the appearance of the test- and refer-ence products are very different in the look.
Other names: ConvaTec 2-piece
SenSura Uro 2-piece
DeviceSenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)
Other names: SenSura
Primary outcomes
-
Preference of the Two Urostomy Products
Time frame: 6 weeks
Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product.
The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred.
Sponsors and collaborators
Lead sponsor
Coloplast A/S
Industry
Registry information
Official study title
A Comparative, Randomised, Crossover Study With SenSura Uro 2-piece Versus ConvaTec 2-piece Among 30 Urostomy-operated Persons in Germany
Important dates
- Study start
- 2008
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Sep 29, 2008
- Registry last updated
- Jan 1, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.