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NCT06224933NARecruitingAccepts Healthy Volunteers

Augmented Reality For MRI-Guided Interventions

Children's National Research Institute

Start Date

2/6/2024

Completion Date

5/31/2026

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.

Eligibility Criteria

Age Range: 3 years to 21 years

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 3 to 21 * Patient referred to Interventional Radiology for image-guided needle injection, aspiration, or biopsy. Exclusion Criteria: * 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.

Interventions

DEVICE

Augmented Reality System

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Conditions

InfectionsPainDiagnosis

Locations

Children's National Hospital

Washington D.C., District of Columbia 20010

United States