Autonomous Blood Drawing Optimization and Performance Testing

Autonomous Blood Drawing Optimization and Performance Testing

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, B3, 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).

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.