A multicenter trial reports Vitestro’s autonomous robotic phlebotomy system achieved high first-stick success rate across 1,633 patients in routine clinical settings.
Vitestro announced the publication of a multicenter clinical trial in Clinical Chemistry evaluating its autonomous robotic phlebotomy system, Aletta. The study represents the first peer-reviewed multicenter evaluation of a fully autonomous system using multimodal imaging to perform diagnostic venous blood draws in routine clinical practice.
The trial, which is part of the Autonomous Blood Drawing Optimization and Performance Testing clinical trial, reported results from 1,633 patients enrolled across three outpatient phlebotomy departments in the Netherlands. According to the study, the system achieved an overall first-stick success rate of 94.5% when a suitable vein was identified.
Performance remained consistent across difficult patient populations, including a 97.4% first-stick success rate in patients with a body mass index greater than 30 kg/m2, 92.7% in patients with self-reported difficult venous access, and 93.4% in patients older than 65 years.
Safety and Patient Experience Results
The study reported a hemolysis rate of 0.3%, which the company states is lower than rates typically reported for manual phlebotomy. The adverse event rate was 0.6%, with all events categorized as mild.
Patient feedback indicated that 90% of participants experienced pain levels that were less than, far less than, or similar to manual phlebotomy. Additionally, 82% of patients reported they would prefer the use of the robotic system in the future or had no preference. A separate patient acceptance study conducted at Mayo Clinic in Rochester, Minnesota, found that 86% of patients were willing to use the device for their blood draw.
“This multicenter study represents a significant milestone in the clinical validation of autonomous robotic phlebotomy in routine practice,” says Robert de Jonge, PhD, professor and head of the department of laboratory medicine at Amsterdam University Medical Center, in a release. “The demonstration of strong performance and safety outcomes is critical to building clinical and laboratory confidence in this new approach.”
Standardizing the Preanalytical Phase
The Aletta system uses multimodal imaging, including near-infrared vein visualization, real-time ultrasound, and Doppler ultrasound to distinguish between veins and arteries. The technology combines these imaging capabilities with artificial intelligence and robotics to identify suitable veins and guide needle insertion for blood collection.
“From a laboratory perspective, consistency in the preanalytical phase is critical, yet often difficult to achieve in daily practice,” says Thijs van Holten, PhD, clinical chemist at St Antonius Hospital, in a release. “Aletta introduces a standardized approach to diagnostic blood collection, with the potential to reduce variability, improve sample quality, and support more reliable diagnostic outcomes.”
The system is designed to support high-volume outpatient settings by addressing staffing challenges and reducing human-dependent variability. While the device is currently CE-marked and in use in Europe, it has not yet received Food and Drug Administration authorization for use in the US.
Photo caption: Aletta system
File photo/provided Vitestro
