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

Area of Science:

• Medical Technology
• Clinical Diagnostics
• Robotics in Healthcare

Background:

• Automated phlebotomy offers potential benefits for patient outcomes and addresses workforce shortages.
• The Autonomous Blood Drawing Optimization and Performance Testing (ADOPT) trial evaluated an autonomous robotic phlebotomy device (ARPD) using multimodal imaging.

Purpose of the Study:

• To assess the performance, safety, and patient experience of an ARPD.
• To compare the analytical equivalence of ARPD-collected samples with manually collected samples.
• To evaluate the ARPD in a routine clinical setting.

Main Methods:

• Two cohorts were used: Cohort 1 for analytical equivalence (Passing-Bablok regression) and Cohort 2 for routine use assessment.
• Primary endpoints included first-stick success rate and adverse event rate.
• Exploratory endpoints focused on patient-reported pain and preference.

Main Results:

• Analytical equivalence was confirmed for key blood parameters (e.g., aPTT, PT, LDH, AST, platelets).
• The ARPD achieved a 94.5% first-stick success rate overall, maintaining high rates in challenging patient groups.
• Mild adverse events occurred at 0.6%, with 90% of patients reporting similar or less pain and 82% preferring future ARPD use.

Conclusions:

• The ARPD demonstrates a favorable performance and safety profile for automated phlebotomy.
• The device has the potential to enhance patient experience during blood collection.
• The ADOPT trial (NCT05878483) provides evidence for the clinical utility of robotic phlebotomy.