The purpose of this research is to evaluate the safety and feasibility of using a needle guidance system (LUMENA) create by CLEAR GUIDE MEDICAL for needle placement for biopsy or liver tumor ablation procedures.
The purpose of this research is to evaluate the safety and feasibility of using a needle guidance system (LUMENA) create by CLEAR GUIDE MEDICAL for needle placement for biopsy or liver tumor ablation procedures. The MRI compatible guidance system will not change the needle biopsy or ablation procedure but will provide the doctor doing the procedure with an augmented reality display to better track the needle path as it is being inserted in the target. Otherwise, the procedure will be carried out in the same manner as it is currently done under MRI or CT or X-ray guidance. Participants who have been scheduled for the guided biopsy or ablation procedure of the liver will be invited to take part in this research. Study participation involves one study visit. Participants will be in the study until the biopsy or ablation procedure is completed. The biopsy procedure will take approximately 60 minutes to complete. The ablation procedure will take approximately 4 hours to complete.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
For the use of the MRI-needle guidance system (LUMENA) developed by CLEAR GUIDE MEDICAL during clinical MRI-guided needle placement procedures for patients undergoing a liver biopsy/procedure.
Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGFeasibility of intervention
Use of the guidance system will be considered feasible if the system is used successfully in more than 80% of procedures
Time frame: Baseline (during procedure)
Safety of intervention (adverse events)
Participants will be monitored for adverse events during the procedure and during recovery time following the procedure. The intervention will be considered safe if the needle is successfully placed in the target with no serious adverse events and total adverse events \<10%.
Time frame: Up to 4 hours
Number of needle passes
Recorded during the procedure by a member of the technical staff who will be there monitoring use of the guidance system.
Time frame: Baseline (during procedure)
Procedure time
Procedure time will be recorded. Start time will be when initial imaging is obtained (planning image). The end time will be when the final imaging is taken (needle placement completed).
Time frame: Baseline (during procedure)
Accuracy of needle placement
Assessed using MRI images showing needle placement, planned versus actual.
Time frame: Baseline (during procedure)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.