Sharps InjuriesNCT07898111
A Study of VAX-ID® 2200, a New Device for Intradermal Injections
An observational study of Sharps Injuries, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sharps Injuries
- What is being tested?
- VAX-ID® 2200
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2026to 11 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Nurses, Clinicians and Pharmacists
Who may be able to join
- Licensed healthcare professionals (nurses, doctors, or pharmacists)
- Willing to provide informed consent and comply with study instructions and procedures.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
About this study
Official title: Usability Assessment and Sharps Injury Prevention Testing Protocol for VAX-ID® 2200: A Human Factors Engineering (HFE) Study by Healthcare Professionals
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.
Read the detailed description
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
- Conditions
- Sharps Injuries
- Being tested
- VAX-ID® 2200
- Keywords
- VAX-ID® 2200, Human Factors Engineering, Sharps Injury Prevention Testing, 26-323
- Medical subject headings
- Needlestick Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAX-ID® 2200Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Health professionals | 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. Receives: Device: VAX-ID® 2200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start11 Sep 2026
- Primary completion11 Sep 2027 (estimated)
- Study completion11 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sharps InjuriesStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- IDEVAX
- Responsible party
- Sponsor
- Investigators
- Jess Brallier, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898111
- Sponsor's protocol ID
- 26-323
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Assessment and Sharps Injury Prevention Testing Protocol for VAX-ID® 2200: A Human Factors Engineering (HFE) Study by Healthcare Professionals
- ClinicalTrials.gov ID
- NCT07898111
- Acronym / sponsor ID
- 26-323
- Conditions
- Sharps Injuries
- Keywords
- VAX-ID® 2200, Human Factors Engineering, Sharps Injury Prevention Testing, 26-323
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- IDEVAX
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- 11 Sep 2027 (estimated)
- Study completion
- 11 Sep 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health professionals | – | Device: VAX-ID® 2200Participants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nurses, Clinicians and Pharmacists
Key inclusion criteria (2 listed)
- Licensed healthcare professionals (nurses, doctors, or pharmacists)
- Willing to provide informed consent and comply with study instructions and procedures.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAX-ID® 2200This 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. | Device | Health professionals |
Primary outcome
assess whether the injury prevention mechanism of the VAX-ID® 2200 function
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Sharps Injuries
Not yet recruiting
AI-Supported Gamified Training for Sharps Injury Prevention in Nurses
Sharps Injuries, Needlestick Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jess Brallier, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sharps Injuries, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess whether the injury prevention mechanism of the VAX-ID® 2200 function (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.