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Clinical Trial 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, 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, C1, C2 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 is included in a non-hospital site (Vitestro Site).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05878483
Study type Interventional
Source Vitestro B.V.
Contact Luuk Giesen, MD
Phone +31 30 200 45 51
Email luuk.giesen@vitestro.com
Status Recruiting
Phase N/A
Start date July 21, 2023
Completion date July 2025

See also
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