NCT06224933

Augmented Reality For MRI-Guided Interventions

Augmented Reality Real-Time Guidance for MRI-Guided Interventions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 3 Years – 21 Years
• Healthy volunteers: Accepted

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.

Detailed description

This pilot clinical study is designed to evaluate the feasibility of using a needle guidance system during MRI-guided procedures in up to 12 patients. The MRI-compatible needle guidance system was developed under an NIH funded SBIR Phase II grant. This system has been evaluated by our Interventional Radiology team in phantom, volunteer, and cadaver studies which showed potential benefit of use in patients. Inclusion of the needle guidance system will not change the standard of care or substantively affect procedural technique as currently performed. This system provides the operator with an augmented reality (AR) display to better visualize the needle entry point and trajectory as it is inserted toward the target. This additional information could improve needle placement accuracy and shorten procedural time.

Conditions

• Infections
• Pain
• Diagnosis

Interventions

Type	Name	Description
DEVICE	Augmented Reality System	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.

Timeline

• Start date: 2024-02-06
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2024-01-25
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study