Augmented Reality Guidance for Liver Procedures

Overseen By Desirae Howe-Clayton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Inability to consent, MR-unsafe implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new needle guidance system called LUMENA, which uses augmented reality to improve needle placement accuracy during liver procedures such as biopsies or tumor treatments. The goal is to determine if this system is safe and effective. It suits individuals needing image-guided liver procedures who have been referred to Interventional Radiology. Participants must be able to undergo MRI scans, as the system operates with these imaging machines. As an unphased trial, this study allows participants to contribute to cutting-edge research in medical technology.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the LUMENA needle guidance system is safe for liver procedures?

Research shows that augmented reality (AR) systems like LUMENA can enhance the safety of liver procedures by improving needle placement accuracy. Previous studies have found that AR can guide surgeries and reduce postoperative complications, potentially resulting in fewer side effects for patients.

Although specific data on LUMENA's safety in humans is not yet available, AR tools are generally considered safe and useful in surgery. This trial tests LUMENA's safety and practicality. The results appear promising, but further research is necessary for confirmation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of augmented reality (AR) guidance in liver procedures because it offers a new level of precision and safety. Unlike traditional methods, which rely heavily on visual estimation or limited imaging techniques, this approach integrates an AR display compatible with MRI to guide needle placements accurately. This innovation holds the promise of reducing errors and improving outcomes in liver biopsies and ablations. By providing real-time, enhanced visualization, it could make complex procedures more accessible and less invasive.

What evidence suggests that the LUMENA needle guidance system is effective for liver procedures?

Research has shown that the LUMENA system, which uses augmented reality (AR) to guide doctors, can improve the accuracy of needle placement in liver procedures. In this trial, participants will undergo MR-guided needle placement using the LUMENA system. One study found that AR guidance enabled doctors to achieve a high accuracy of 3.4 mm, successfully treating all targeted liver areas. This precision is crucial for effective biopsies and tumor treatments. Another study highlights that AR systems generally enhance image-guided procedures by increasing accuracy and efficiency. Overall, these findings suggest that LUMENA could make liver procedures safer and more effective by ensuring precise needle placement. ^{1 3 6 7 8}

Who Is on the Research Team?

David A. Woodrum, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 who need a liver biopsy or tumor ablation and can follow the study's procedures. They must be able to give consent and fit into an MRI scanner with space for needle placement. People with MRI-unsafe implants or those unable to consent are excluded.

Inclusion Criteria

I am between 18 and 90 years old.

I am willing and able to follow all study requirements.

Provision of signed and dated informed consent form

Exclusion Criteria

Contraindications to MRI such as MR-unsafe implants.

Patients that do not fit into MR scanner (70 cm bore) with room for needle placement

I cannot give consent myself and do not have a parent to consent for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo a biopsy or ablation procedure with MRI-guided needle placement using an augmented reality display

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

Up to 4 hours

What Are the Treatments Tested in This Trial?

Interventions

• LUMENA

Trial Overview The trial is testing LUMENA, a new system by CLEAR GUIDE MEDICAL designed to help doctors place needles accurately in the liver during biopsies or tumor treatments using real-time guidance from MRI images.

How Is the Trial Designed?

Group I: MR-guided needle placement Experimental Treatment 1 Intervention

An augmented reality display compatible with MRI will be used to assist with guidance of needle placement for biopsy or ablation procedure.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. withpower.com withpower.com/trial/phase-liver-6-2025-2c4b3

Augmented Reality Guidance for Liver Procedures This N/A medical study run by Mayo Clinic is evaluating whether LUMENA will have tolerable side effects & efficacy for patients with Liver.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8909771/

Thermal Ablation of Liver Tumors Guided by Augmented ... The high targeting accuracy (3.4 mm; 2.6–4.2 mm, mean) was accompanied by technical success in all 15 lesions (i.e., the complete ablation of ...

3. jmirs.org jmirs.org/article/S1939-8654(23)01940-9/fulltext

The applications of augmented reality in image-guided ... Conclusion. AR systems enhance image-guided tumor ablations by improving the accuracy of ablation probe placements and increasing efficiency.

4. ichgcp.net ichgcp.net/clinical-trials-registry/548645-augmented-reality-real-time-guidance-for-mri-guided-interventions

Augmented Reality MRI Guidance for Liver Biopsies &amp Patients participating in this single-group study will experience either a biopsy (approximately 60 minutes) or tumor ablation (about 4 hours), ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878788623000139

Augmented reality in liver surgery Augmented reality (AR) enables surgeons to enrich their vision of the operating field by means of digital imagery, particularly as regards tumors and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408658/

Assessing augmented reality displays in laparoscopic liver ... Augmented Reality (AR) is considered as a potential image guidance tool to increase the safety of laparoscopic liver surgery.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772947825000258

Integrating mixed reality, augmented reality, and artificial ... The approach improved surgical safety, preserved liver function, and reduced postoperative complications, showcasing the effectiveness of augmented and mixed ...

8. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07120906

MRI guided procedure software evaluation in Liver - ICH GCP An augmented reality display compatible with MRI will be used to assist with guidance of needle placement for biopsy or ablation procedure.