At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Comparative, Randomised, Crossover Study With SenSura Uro 2-piece Versus ConvaTec 2-piece Among 30 Urostomy-operated Persons in Germany
In Brief
A Phase 3 clinical trial evaluating Convatec Uro 2-piece and SenSura Uro 2-piece for Urostomy Patent. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.
Study Details
Timeline
Interventions
Specific 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.
SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)