NCT01800890

Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy

Investigating the Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.

Detailed description

The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.

Conditions

• Subjects With an Ileostomy

Interventions

Type	Name	Description
DEVICE	Coloplast A	Coloplast A is a newly developed 2-piece ostomy appliance
DEVICE	Coloplast B	Coloplast B is a newly developed 2-piece ostomy appliance
DEVICE	Coloplast C	Coloplast C is a newly developed 2-piece ostomy appliance
DEVICE	SenSura Click	The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2013-02-28
• Last updated: 2014-08-06
• Results posted: 2014-08-06

Locations

1 site across 1 country: Denmark