Augmented Reality Real-Time Guidance for MRI-Guided Interventions
NCT ID: NCT07120906
Last Updated: 2025-08-26
Study Results
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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RECRUITING
NA
10 participants
INTERVENTIONAL
2025-07-25
2026-12-31
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 that do not fit into MR scanner (70 cm bore) with room for needle placement.
* Contraindications to MRI such as MR-unsafe implants.
18 Years
90 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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David A. Woodrum
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
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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24-011504
Identifier Type: -
Identifier Source: org_study_id
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