Study of Autonomous Blood Drawing Device for Improving Blood Collection Safety and Performance in Outpatient Settings

What this Trial Is About

This research aims to evaluate how well an autonomous blood drawing device works and whether it is safe. The study includes several phases, with Phase B1 being a key clinical trial to confirm that the device performs at least as well as manual blood drawing, which is important for regulatory approval. Earlier and later phases focus on improving the technology and usability, including testing non-invasive features like ultrasound detection. Participants will receive blood draws using the Venipuncture Device, which fully automates the procedure by detecting veins with near-infrared and ultrasound imaging, inserting a needle robotically, connecting blood tubes, and applying pressure to the puncture site. Depending on the phase, the device may replace or supplement manual blood draws. Some phases involve one or two automated draws, and the technology is progressively improved, with more manual steps required in early phases and fewer later on. During the study, participants will undergo standard blood drawing procedures at outpatient blood drawing departments or at a volunteer site. Researchers will measure the success rate of first-time venipuncture, the rate of punctured participants, hemolyzed samples, and adverse events over seven days. The study includes safety monitoring, and participant involvement varies by phase, with some receiving additional automated blood draws beyond routine care.

Autonomous Blood Drawing Optimization and Performance Testing