Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 7:36 PM
Study NCT ID:
NCT07120906
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmented Reality Real-Time Guidance for MRI-Guided Interventions
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Augmented Reality Real-Time Guidance for MRI-Guided Interventions
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: