NCT01517178

Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care

An Open-labelled, Randomised, Controlled, Comparative, Multi-national, Cross-over Study Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared to 2-piece Standard Care Ostomy Products

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates. The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates. Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods. The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period. 100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.

Conditions

• Leakage
• Skin Condition

Interventions

Type	Name	Description
DEVICE	New ostomy base plate (SS)	The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
DEVICE	Standard Care base plate	The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2012-01-25
• Last updated: 2015-03-13
• Results posted: 2015-03-13

Locations

11 sites across 4 countries: Denmark, France, Germany, Iceland