3 results
Approved WMOCompleted
Pilot study:Primary objective: feasibilitySecondary objectives: response rate, time to progression, overall survival and quality of life.Phase II study:Primary objective: efficacy.Secondary objectives: toxicity, especially grade 3 and 4 toxicities,…
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.