NCT05878483

Autonomous Blood Drawing Optimization and Performance Testing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44,658 (estimated)
• Sponsor: Vitestro B.V. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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).

Conditions

• Venipuncture
• Phlebotomy

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-07-21
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2023-05-26
• Last updated: 2026-04-07

Locations

5 sites across 1 country: Netherlands