Testing a device for automated blood drawing
Official title: Autonomous Blood Drawing Optimization and Performance Testing
Run by Vitestro B.V. · NCT05878483 · Data updated 2026-11-12
This study is testing a new automatic device for drawing blood to see if it works as well as the traditional method done by a nurse or technician.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 44658 (estimated) |
| Sponsor | Vitestro B.V. Industry-sponsored |
| Locations | 7 sites (Copenhagen and 6 other locations) |
| Status | Recruiting |
| Started | July 21, 2023 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | August 14, 2026 |
| Trial ID | NCT05878483 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 16 and older who require venipuncture and meet the inclusion criteria.
✕Probably not a fit
Patients with severe physical impairments or conditions that prevent venipuncture in both arms will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study evaluates the performance and safety of an autonomous blood drawing device designed to perform venipuncture. It includes several phases, with Phase B1 focusing on confirming the device's non-inferiority compared to manual blood drawing. Other phases explore technology improvements and usability testing. The study takes place in outpatient blood drawing departments and includes both patients and a small number of volunteers in non-hospital settings.
Why it matters
Potential benefit: If successful, this device could make blood drawing safer, more efficient, and less painful for patients.
How similar studies have gone: While the concept of autonomous blood drawing is innovative, similar studies have shown promise in robotic assistance for medical procedures, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: • Age ≥16 years. Exclusion Criteria: * Unable to follow instructions, due to mental disability and/or incapacity * Unable to use device correctly due to physical impairment or disability (for example a patient with severe contractures or deformities) * No venipuncture possible in cubital fossa of both arms (for example: after amputation of both arms) * No venipuncture possible in cubital fossa due to contra-indications in both arms (for example: tattoos in both arms) * Incapacitated persons * Pregnant or breast-feeding The following contra-indications / exclusion criteria are respected per arm: * Arteriovenous fistula or vascular graft * Paretic or paralyzed arm (e.g. after stroke or trauma) * Infected skin in cubital fossa (for example: erysipelas or cellulitis) * Mastectomy side, axillary lymph node excised * Healed skin burns in cubital fossa * Edema in cubital fossa * Extensive scarring in cubital fossa * Hematoma in cubital fossa * Tattoos in cubital fossa In case the test subject has a suitable contralateral arm, the subject can be included in this study. In Study Phase B2 or B3, venipunctures are performed in both arms. Patients who have a contra-indication in one arm are excluded from the Phase B2 and Phase B3 study.
Where it's running
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Bispebjerg and Frederiksberg Hospital
Copenhagen, Denmark Recruiting -
Odense University Hospital
Odense, Denmark Recruiting -
OLVG Lab
Amsterdam, North Holland, Netherlands Recruiting -
Amsterdam UMC
Amsterdam, North Holland, Netherlands Recruiting -
Result Laboratorium, location Albert Schweitzer Hospital
Dordrecht, South Holland, Netherlands Recruiting -
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands Recruiting
Show 1 more location
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Vitestro
Utrecht, Utrecht, Netherlands Not yet recruiting
Study contacts
- Principal investigator: Luuk Giesen, MD — Vitestro B.V.
- Study coordinator: Luuk Giesen, MD
- Email: luuk.giesen@vitestro.com
- Phone: +31 30 200 45 51
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Rhythmic Skin Tapping and Internal Vibration for Pediatric Venipuncture Pain and Fear
This study tests whether light fingertip tapping above the needle site or a humming sound can reduce pain and fear in children aged 6-12 during blood draws.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.