Autonomous Blood Drawing Optimization and Performance Testing

Launched by VITESTRO B.V. · May 17, 2023

Keywords

ClinConnect Summary

**Trial Summary: Autonomous Blood Drawing Optimization and Performance Testing**

This clinical trial is testing a new device designed to draw blood automatically, which could make the process easier and safer for patients. The study aims to see how well this device works compared to the traditional method where a nurse or technician draws blood manually. Researchers want to ensure that the new device can perform just as well and safely. The trial is taking place in outpatient blood drawing departments, and they are currently looking for participants.

To be eligible for this study, you need to be at least 16 years old and able to follow instructions. However, certain individuals may not qualify, such as those with mental or physical disabilities that would prevent them from using the device correctly, or if there are issues in both arms that make blood drawing impossible, like severe injuries or tattoos in the area. Participants will have the chance to experience both the manual and automated blood drawing methods during the trial, and this could lead to improvements in how blood is collected in the future. If you're interested in participating, it’s a great opportunity to contribute to medical advancements!

Gender

ALL

Eligibility 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, a manual venipuncture and automated venipuncture are performed in both arms. Patients who have a contra-indication in one arm are excluded from the Phase B2 study.