2 results
Approved WMOCompleted
Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…
Approved WMOWill not start
The primary objective is to investigate feasibility (number of successful automated venipunctures) and safety (number of adverse events and adverse device events). Secondary objectives are to determine subject's pain experience, duration of…