Evaluating Safety and Feasibility of LUMENA MRI-Compatible Needle Guidance System for Liver Biopsy and Ablation Procedures

What this Trial Is About

Researchers are evaluating the safety and feasibility of a new needle guidance system called LUMENA, developed by CLEAR GUIDE MEDICAL, designed to aid in needle placement during liver biopsy or tumor ablation procedures. This study focuses on using augmented reality to enhance real-time tracking of the needle path during MRI-guided interventions for liver conditions. Participants will undergo liver biopsy or ablation procedures assisted by the MRI-compatible LUMENA guidance system that provides an augmented reality display to help doctors track needle placement more accurately. The guidance system does not change the standard procedure but supports the physician during the intervention. The biopsy procedure lasts about 60 minutes, while the ablation procedure takes approximately 4 hours. Participants will have one study visit, remaining in the study until their biopsy or ablation procedure is completed. Researchers will assess the feasibility and safety of using the device during the procedure, including monitoring adverse events up to 4 hours post-procedure. Secondary measures include the number of needle passes, procedure time, and accuracy of needle placement. The study is sponsored by Mayo Clinic and runs until the end of 2026.

Augmented Reality Real-Time Guidance for MRI-Guided Interventions