NCT01513330

Performance Study of Newly Developed Ostomy Products

An Open-labelled, Randomised, Controlled, Crossover Investigation Evaluating Performance of a Newly Developed Ostomy Care Product Compared to Standard Care.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.

Conditions

• Stoma Colostomy

Interventions

Type	Name	Description
DEVICE	SenSura Mio	Ostomy product - 1 piece closed bag
DEVICE	Standard Care	Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-06-01
• Completion: 2012-08-01
• First posted: 2012-01-20
• Last updated: 2014-01-09
• Results posted: 2014-01-09

Locations

1 site across 1 country: Germany