NCT02507726

Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: BBraun Medical SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.

Detailed description

Primary outcome Measure: To describe Investigational Device performance in term of level of leakage under the skin protector Secondary Outcome Measure: * Assessment of the condition of peristomal skin * Assessment of other performance criteria * Assessment of AEs for each patient

Conditions

• Enterostomy

Interventions

Type	Name	Description
DEVICE	Flexima Active soft convexe	The Investigational Device will be used during 14 +- 3 days.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-07-24
• Last updated: 2016-09-23

Locations

1 site across 1 country: France