NCT01800916

Safety and Performance of New 1-piece Ostomy Product

Investigating the Safety and Performance of New 1-piece Ostomy Product Concepts Compared With SenSura 1-piece in Subjects With an Ileostomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.

Detailed description

The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.

Conditions

• Stoma Ileostomy

Interventions

Type	Name	Description
DEVICE	Coloplast Adhesive baseplate A	Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.
DEVICE	Coloplast Adhesive baseplate B	Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance
DEVICE	Coloplast Adhesive baseplate C	Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance
DEVICE	SenSura 1-Piece	SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2013-02-28
• Last updated: 2017-04-14
• Results posted: 2014-05-30

Locations

1 site across 1 country: Denmark