A Study Of Augmented Reality Real-Time Guidance With In-situ Feedback

Feasibility will be assessed as the proportion of procedures successfully completed using the LUMENA guidance system without withdrawal of the system before completion. The procedure will be considered feasible if more than 80% of procedures are completed using the system.

Safety will be assessed by the occurrence of serious adverse events and total adverse events associated with the procedure. The safety endpoint is safe needle placement in the target without any serious adverse events and total adverse events less than 10%.

Needle placement accuracy will be assessed by comparing the planned target location on the planning CT image set with the actual needle tip location on the confirmatory CT image set. Accuracy will be calculated as the three-dimensional distance between the planned target and actual needle tip location, reported in millimeters.

Procedure time will be measured from acquisition of the initial imaging to acquisition of the final imaging and reported in minutes.

The number of intermediary CT/fluoroscopy images obtained during the procedure will be recorded as an indirect measure of radiation exposure.

At the end of each procedure, the operator will complete a usability form that captures ease of use using a Likert scale and subjective clinical impressions of system use and utility.