Augmented Reality Real-Time Guidance for MRI-Guided Interventions

Mayo Clinic

Status: Enrolling

Conditions: Liver

Treatments: Device: MRI guided procedure software evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT07120906

24-011504

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

MR-guided needle placement

Experimental group

Description:

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

Treatment:

Device: MRI guided procedure software evaluation