Augmented Reality Real-Time Guidance for MRI-Guided Interventions

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Liver
• Intervention / Treatment: Device: MRI guided procedure software evaluation

Detailed Description

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
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Mayo Clinic in Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 image-guided liver needle placement for ablation/biopsy.

Exclusion Criteria:

• Patients who are unable to give informed consent themselves or through their parents.
• Patients that do not fit into MR scanner (70 cm bore) with room for needle placement.
• Contraindications to MRI such as MR-unsafe implants.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MR-guided needle placement; An augmented reality display compatible with MRI will be used to assist with guidance of needle placement for biopsy or ablation procedure.	Device: MRI guided procedure software evaluation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of intervention	Use of the guidance system will be considered feasible if the system is used successfully in more than 80% of procedures	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%.	Up to 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	Baseline (during procedure)
Accuracy of needle placement	Assessed using MRI images showing needle placement, planned versus actual.	Baseline (during procedure)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: David A. Woodrum, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 30, 2025
• First Submitted That Met QC Criteria: August 6, 2025
• First Posted (Actual): August 13, 2025

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 24-011504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No