NCT01514136

An Investigation of Ostomy Devices

CP216: An Exploratory Investigation of Convex Ostomy Devices

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Coloplast A/S has developed a new ostomy device in 8 versions. The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices. The secondary objective is to investigate several performance and safety parameters of the various devices. The aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed. Given that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development. The investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users. Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each device will be tested for 7 (± 2) days.

Conditions

• Ileostomy

Interventions

Type	Name	Description
DEVICE	Ostomy appliance: convex 1-piece drainable	8 variations of an ostomy devices are tested

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2012-01-20
• Last updated: 2015-03-11
• Results posted: 2015-01-29

Locations

1 site across 1 country: Denmark