Testing a device for automated blood drawing
Autonomous Blood Drawing Optimization and Performance Testing
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44658 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Vitestro B.V. Industry-sponsored |
| Locations | 5 sites (Amsterdam, North Holland and 4 other locations) |
| Trial ID | NCT05878483 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and older who require venipuncture and meet the inclusion criteria.
Not a fit: Patients with severe physical impairments or conditions that prevent venipuncture in both arms will not benefit from this study.
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 performed: While the concept of autonomous blood drawing is innovative, similar studies have shown promise in robotic assistance for medical procedures, indicating potential for success.
Eligibility criteria
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 this trial is running
Amsterdam, North Holland and 4 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.