Enterostomy Clinical Trial
Official title:
Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy
This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.
Primary outcome Measure:
To describe Investigational Device performance in term of level of leakage under the skin
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Secondary Outcome Measure:
- Assessment of the condition of peristomal skin
- Assessment of other performance criteria
- Assessment of AEs for each patient
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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