Actively Recruiting
Autonomous Blood Drawing Optimization and Performance Testing
Led by Vitestro B.V. · Updated on 2026-04-07
44658
Participants Needed
5
Research Sites
336 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Autonomous Blood Drawing Optimization and Performance Testing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 16 years
You will not qualify if you...
- Unable to follow instructions due to mental disability or incapacity
- Unable to use the device correctly due to physical impairment or disability such as severe contractures or deformities
- No venipuncture possible in the cubital fossa of both arms due to reasons like amputation or tattoos
- Incapacitated persons
- Pregnant or breastfeeding
- Arteriovenous fistula or vascular graft in the arm
- Paretic or paralyzed arm (e.g., after stroke or trauma)
- Infected skin in the cubital fossa (e.g., erysipelas or cellulitis)
- Mastectomy side or axillary lymph node removed
- Healed skin burns in the cubital fossa
- Edema in the cubital fossa
- Extensive scarring in the cubital fossa
- Hematoma in the cubital fossa
- Tattoos in the cubital fossa
- Patients with contraindications in one arm are excluded from Phases B2 and B3 where venipunctures are performed on both arms
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
OLVG Lab
Amsterdam, North Holland, Netherlands, 1091 AC
Actively Recruiting
2
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
3
Result Laboratorium, location Albert Schweitzer Hospital
Dordrecht, South Holland, Netherlands, 3318 AT
Actively Recruiting
4
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435CM
Actively Recruiting
5
Vitestro
Utrecht, Utrecht, Netherlands, 3526KS
Not Yet Recruiting
Research Team
L
Luuk Giesen, MD
CONTACT
J
Jeroen Roest, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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