An interventional study of Augmented Reality System in Infections, Pain and Diagnosis, sponsored by Children's National Research Institute. Recruiting at 1 site in United States. Open to participants aged 3 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Children's National Research Institute · Not applicable, Interventional, and Device feasibility
The purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing MRI-Guided needle procedures.
This pilot clinical study is designed to evaluate the feasibility of using a needle guidance system during MRI-guided procedures in up to 12 patients. The MRI-compatible needle guidance system was developed under an NIH funded SBIR Phase II grant. This system has been evaluated by our Interventional Radiology team in phantom, volunteer, and cadaver studies which showed potential benefit of use in patients. Inclusion of the needle guidance system will not change the standard of care or substantively affect procedural technique as currently performed. This system provides the operator with an augmented reality (AR) display to better visualize the needle entry point and trajectory as it is inserted toward the target. This additional information could improve needle placement accuracy and shorten procedural time.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 25 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Children's National Research Institute is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will undergo their standard of care image-guided needle biopsy, aspiration, or injection with the Augmented Reality system. Patients will be monitored for adverse events for two weeks following their procedure.
Device: Augmented Reality System
Subjects will undergo image guided needle aspiration, injection, or biopsy facilitated by the Augmented Reality system. The Augmented Reality guidance system will be operated by the interventional radiologist in the MRI suite.
Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system.
Time frame: 1 day
Safety of using the augmented reality needle guidance system will be evaluated through assessment of procedure related adverse events that occur within 7 days of the procedure.
Time frame: 7 days
Procedure time
Total procedure time.
Time frame: 1 day
Number of MRI scans
Number of MRI scans needed to complete the procedure, and size and depth of target will be recorded.
Time frame: 1 day
Clinical impressions of the system use and utility
The operator will complete a usability form that captures ease of use using the Likert scale.
Time frame: 1 Day
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Children's National Research Institute