3 results
Approved WMOCompleted
The primary objective of this clinical investigation is to investigate the effect of the Provox Luna system on compliance of HME use. Compliant use is defined as daily use of an HME for at least 20 hours per day 86% (=24/28; each study period is 4…
Not approvedWill not start
The objective of this clinical investigation is to evaluate the clinical performance of Provox Luna in comparison to the usual care of the patient.
Approved WMOWill not start
The aim of this investigation is to investigate the performance and safety of a new baseplate comprising a protective layer, which is expected to reduce peristomal skin complications induced by output.