RecruitingNot ApplicableNCT05878483

Autonomous Blood Drawing Optimization and Performance Testing


Sponsor

Vitestro B.V.

Enrollment

44,658 participants

Start Date

Jul 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this pre-market clinical study is to evaluate the performance (efficacy) and safety of an autonomous blood drawing device (Venipuncture Device). The study consists of several phases (A, B1, B2, C1, C2, C3, 0). Phase B1 is a confirmatory, Pivotal Clinical Study, required for regulatory approval, in which non-inferiority should be demonstrated in comparison to manual blood drawing. Phases A, B2, B3, C1, C2, C3 are all exploratory studies, in which the technology and usability is further improved and tested. Phase 0 is an exploratory study for non-invasive technology testing (for example for improvement of ultrasound detection). The study locations are outpatient blood drawing departments, in which patients are included as subjects. Additionally, in Phase A and C1, a small number of volunteers can be included in a non-hospital site (Vitestro Site).


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a robotic device designed to draw blood automatically, without a human phlebotomist. Blood draws are a routine but often anxiety-inducing part of medical care, and finding a reliable automated alternative could reduce wait times, improve consistency, and expand access in under-resourced settings. The device targets the antecubital fossa — the soft area inside the elbow — which is the standard site for venipuncture. Adults 16 years and older with accessible veins in at least one arm are eligible. You cannot participate if you are pregnant or breastfeeding, have a physical or mental impairment that prevents following instructions, have arteriovenous fistulas, active skin infections, tattoos, or significant scarring in both elbow areas, or have had a mastectomy with lymph node removal on both sides. Participants will have their blood drawn by both the automated device and a human phlebotomist, and outcomes such as success rate, comfort, and sample quality will be compared. This research is an important step toward validating autonomous medical procedures — if the robot performs as well as a trained human, it could transform routine healthcare delivery, particularly in high-volume labs and remote clinics.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVenipuncture Device (VD)

The Venipuncture Device is a pre-market medical device that fully automates the blood drawing procedure (also called phlebotomy or venipuncture). It automatically detects a vein using near-infrared and ultrasound imaging technology, robotically inserts a needle, automatically connects blood tubes and applies pressure to the puncture site. During the ADOPT Study, the technology is further improved over time; for example features are released (such as: automated tourniquet). Initially, several manual steps are required to be performed by a device supervisor and operator. At the final stage of the ADOPT Study, Phase C2 and Phase C3, the device has full functionality and only limited manual steps are required to be performed by a device supervisor.


Locations(5)

OLVG Lab

Amsterdam, North Holland, Netherlands

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Result Laboratorium, location Albert Schweitzer Hospital

Dordrecht, South Holland, Netherlands

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Vitestro

Utrecht, Utrecht, Netherlands

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NCT05878483


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