An observational study in Sharps Injuries, sponsored by Memorial Sloan Kettering Cancer Center. Enrolling by invitation at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Memorial Sloan Kettering Cancer Center · Observational
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
30 studies on the registry are indexed under Needlestick Injuries; 3 are open to participants now.
Browse Needlestick Injuries studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.
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Nurses, Clinicians and Pharmacists
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will engage in simulated use testing by executing injections on a 3D-printed patch model after receiving standardized training materials that simulate real-world use conditions. These include the comprehensive Instructions for Use (IFU) and a video presentation. A total of 2 trained observers will record user interactions during the simulated-use injections, assessing all tasks and focusing on critical ones, and will categorize these interactions as success, difficulty encountered, close call incidents, or use errors.
Device: VAX-ID® 2200
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.
assess whether the injury prevention mechanism of the VAX-ID® 2200 function
Trained observers (2 per session) will collect data through observation, video recording, and standardized forms with post-use questions/interview debriefs. Tasks will be categorized as success, difficulty, close call, or use error, with special attention to critical tasks. Any difficulty or failure (use error) will undergo a root cause analysis.
Time frame: 1 year
Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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