About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, ages 18-90 years
Patient referred to Interventional Radiology for CT-guided needle placement for ablation/biopsy.
Disqualifiers
Patients who are unable to give informed consent themselves or through their parents.
Patients that do not fit into the gantry of the CT scanner.
Patients who are sensitive to radiation exposure such as pregnant women.
Trial design
Single group
Treatments tested in this trial
LUMENA Guidance System
DeviceLUMENA is an augmented reality needle guidance system that provides real-time visual guidance during CT-guided needle placement procedures.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility 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.
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%.
Secondary outcomes
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.
Procedure time
Procedure time will be measured from acquisition of the initial imaging to acquisition of the final imaging and reported in minutes.
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.
Operator usability assessment of the LUMENA guidance system
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.
Sponsors and contacts
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