Performance, Safety, and Patient Experience of an Autonomous Robotic Phlebotomy Device: A Multicenter Trial

Automated phlebotomy has the potential to improve patient outcomes and address phlebotomist workforce challenges. The Autonomous Blood Drawing Optimization and Performance Testing trial (ADOPT, ClinicalTrials.gov NCT05878483) assesses performance, safety, and patient experience of an autonomous robotic phlebotomy device (ARPD) that utilizes multimodal imaging.

Patients were recruited from outpatient phlebotomy departments in the Netherlands. In cohort 1, analytical equivalence was assessed by comparing within-subject test results from ARPD-collected and manually collected samples using Passing-Bablok regression analysis.In cohort 2, the ARPD was assessed in routine use. The primary performance endpoint was first-stick success rate; the primary safety endpoint was the rate of adverse events. Exploratory endpoints assessed pain and patient preference.

One hundred fifty-three patients were enrolled in cohort 1. No statistically significant differences were observed in activated partial thromboplastin time, prothrombin time, lactate dehydrogenase, aspartate transaminase, or platelet count, indicating analytical equivalence.A total of 1633 patients were enrolled in cohort 2. The overall first-stick success rate, in patients where the ARPD could identify a suitable vein, was 94.5% (95% CI, 93.3-95.5) and remained high in patients with difficult venous access (92.7%), obesity (97.4%), and age ≥65 years (93.4%). Adverse events, all mild, occurred at a rate of 0.6%. Ninety percent of patients reported far less (19%), less (32%), or similar pain (39%) compared with manual phlebotomy. Eighty-two percent indicated they would strongly prefer (16%) or prefer (31%) use of the ARPD in the future or had no preference (35%).

Automated phlebotomy using the ARPD shows a favorable performance and safety profile and may improve patient experience. ClinicalTrials.gov Registration Number: NCT05878483.