Memorial Sloan Kettering Cancer Center
The researchers are doing this study to find out whether the VAX-ID® 2200 device is safe and easy to use for healthcare professionals who give intradermal injections. The VAX-ID® 2200 is a small device that attaches to a standard syringe and guides the needle to the right depth in the skin. This helps make sure the injection is given correctly every time.
This study does not involve the administration of any investigational drugs or biologics. Since this is a simulated-use trial which will be executed on a 3D-printed model representing human skin and not on real patients, only a saline solution will be used as the injection liquid. All procedures will be conducted under the direct supervision of trained personnel, and participants will be carefully screened based on the pre-defined inclusion/exclusion criteria
Inclusion Criteria: * Licensed healthcare professionals (nurses, doctors, or pharmacists) * Willing to provide informed consent and comply with study instructions and procedures. Exclusion Criteria: * Previous user experience with VAX-ID® 2200. * Physical and sensory limitations affecting device handling (conditions like hand tremors, muscle weakness, vision loss/weakness, and reduced tactile sensitivity)
This study consists of two independent parts which will be executed consecutively to assess the VAX- ID® 2200 intradermal injection system's (1) usability and (2) sharps injury prevention. The study will involve a cohort of 15 licensed healthcare professionals, composed of 3 doctors, 10 nurses, and 2 pharmacists. Our objective is to establish a cohort of at least 15 participants in total in accordance with FDA recommendation \[3\], fully reflecting the diverse global population \[4\] (including approximately 1-2 left-handed individuals). Of these, a subset of 8 healthcare professionals (1 doctor, 6 nurses, and 1 pharmacist) will execute on the evaluation of the sharps injury prevention feature.
Arctuva estimate
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