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Comparison of Two Urostomy Bags (2-piece).

NCT00761748 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-01-01

Study results available
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Summary

Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.

Conditions

  • Urostomy Patent

Interventions

DEVICE

Convatec Uro 2-piece

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.

DEVICE

SenSura Uro 2-piece

SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Daniel Carter, M.Sc · Coloplast A/S

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-01-31
Completion
2009-02-28

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00761748 on ClinicalTrials.gov