Vitestro shares trial results at WorldLab 2024 confirming performance, safety and patient acceptance for breakthrough autonomous blood drawing technology

May 29, 2024
All performance and safety endpoints were met in A.D.O.P.T. Pivotal Trial Study Phase; other key findings include 95% first-stick success and 98% patient acceptance.

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

Vitestro release