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Autonomous Blood Drawing Optimization and Performance Testing
Sponsor: Vitestro B.V.
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).
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
44658
Start Date
2023-07-21
Completion Date
2029-12-31
Last Updated
2026-04-07
Healthy Volunteers
Yes
Conditions
Interventions
Venipuncture 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