Augmented Reality For MRI-Guided Interventions
Augmented Reality Real-Time Guidance for MRI-Guided Interventions
1 other identifier
interventional
25
1 country
1
Brief Summary
The purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing MRI-Guided needle procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedStudy Start
First participant enrolled
February 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
September 5, 2025
August 1, 2025
2.3 years
November 22, 2023
August 28, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system.
1 day
Safety of using the augmented reality needle guidance system will be evaluated through assessment of procedure related adverse events that occur within 7 days of the procedure.
7 days
Secondary Outcomes (3)
Procedure time
1 day
Number of MRI scans
1 day
Clinical impressions of the system use and utility
1 Day
Study Arms (1)
Patients Undergoing Augmented Reality Image-Guided Needle Procedures
EXPERIMENTALPatients will undergo their standard of care image-guided needle biopsy, aspiration, or injection with the Augmented Reality system. Patients will be monitored for adverse events for two weeks following their procedure.
Interventions
Subjects will undergo image guided needle aspiration, injection, or biopsy facilitated by the Augmented Reality system. The Augmented Reality guidance system will be operated by the interventional radiologist in the MRI suite.
Eligibility Criteria
You may qualify if:
- 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 3 to 21
- Patient referred to Interventional Radiology for image-guided needle injection, aspiration, or biopsy.
You may not qualify if:
- Patients who are unable to give informed consent themselves or through their parents.
- Patients under 3 years of age
- Patients over 300 pounds.
- Patients who are claustrophobic and unable to tolerate MRI-guided procedure.
- Contraindications to MRI such as MR-unsafe implants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karun Sharma, MD, PhD
Children's National Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Interventional Radiology
Study Record Dates
First Submitted
November 22, 2023
First Posted
January 25, 2024
Study Start
February 6, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
September 5, 2025
Record last verified: 2025-08