Vitestro announced that Pivotal Trial results from its Autonomous Blood Drawing Optimization and Performance Testing (A.D.O.P.T.) study were shared at IFCC WorldLab 2024 in Dubai.
The two-year A.D.O.P.T. study (NCT05878483) is scheduled to run through 2025 and involves 10,000 patients over five study phases. The study sites include four Dutch hospital labs: St. Antonius Hospital, OLVG Lab, Result Laboratorium, and Amsterdam UMC.
In the now-completed EU Pivotal Trial phase, all performance and safety endpoints were met in a diverse, outpatient study population (age range: 18-92 years; 20% of the study population was difficult to puncture). Furthermore, results from the follow-on study phase show that Vitestro’s technology achieved 95% first-stick success.
Key findings from the study include:
· Ninety-eight percent (98%) of patients indicated acceptance of the new, automated method of blood drawing
· Eighty-three percent (83%) of patients rated the procedure pain as less than or comparable to manual blood draws
· Median time of procedure was 1 minute and 49 seconds
· In vitro hemolysis rate for collected blood samples was 0.6%
· No serious or moderate adverse events occurred
