The purpose of this study is to evaluate the feasibility and safety of using the LUMENA guidance system during clinical procedures in patients undergoing CT-guided needle Placement for kidney, liver, lymph node, abdominal mass and lung ablation/biopsy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
LUMENA is an augmented reality needle guidance system that provides real-time visual guidance during CT-guided needle placement procedures.
Mayo Clinic
Jacksonville, Florida, United States
RECRUITINGFeasibility of completing the CT-guided needle placement procedure using the LUMENA guidance system
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.
Time frame: 2 years
Safety of CT-guided needle placement using the LUMENA guidance system as assessed by adverse events
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%.
Time frame: 2 years
Accuracy of needle placement
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.
Time frame: 1 day
Procedure time
Procedure time will be measured from acquisition of the initial imaging to acquisition of the final imaging and reported in minutes.
Time frame: 1 day
Number of intermediary CT/fluoroscopy images
The number of intermediary CT/fluoroscopy images obtained during the procedure will be recorded as an indirect measure of radiation exposure.
Time frame: 1 day
Operator usability assessment of the LUMENA guidance system
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 1 day