Augmented Reality Real-Time Guidance for MRI-Guided Interventions

NCT07120906 | Recruiting DMC FDA Device

• 1 other identifier: 24-011504
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of needle passes

  Baseline (during procedure)

• Procedure time

  Baseline (during procedure)

• Accuracy of needle placement

  Baseline (during procedure)

Study Arms (1)

MR-guided needle placement

EXPERIMENTAL

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

Interventions

MRI guided procedure software evaluation DEVICE

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.

MR-guided needle placement

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• David A. Woodrum, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Desirae Howe-Clayton

CONTACT

507-255-0111; Howe.Desirae@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 13, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)