NCT02675634

Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.

Conditions

• Ileostomy
• Colostomy

Interventions

Type	Name	Description
DEVICE	Coloplast Test A	Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
DEVICE	Coloplast Test B	Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
DEVICE	Subjects own product	The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-02-05
• Last updated: 2017-10-16
• Results posted: 2017-09-05

Locations

12 sites across 4 countries: United States, Denmark, Netherlands, United Kingdom