Augmented Reality Real-Time Guidance for MRI-Guided Interventions

NCT ID: NCT07120906

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-25

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MRI guided procedure software evaluation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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David A. Woodrum

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David A. Woodrum, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Desirae Howe-Clayton

Role: CONTACT

507-255-0111

Facility Contacts

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Desirae Howe-Clayton

Role: primary

507-255-0111

Related Links

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Other Identifiers

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24-011504

Identifier Type: -

Identifier Source: org_study_id

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