Augmented Reality For MRI-Guided Interventions

Children's National Research Institute25 enrolled

Overview

The purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing MRI-Guided needle procedures.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Infections Pain Diagnosis

Interventions

Augmented Reality SystemDEVICE

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

Sex: ALLMin age: 3 YearsMax age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Children's National Hospital

Washington D.C., District of Columbia, United States

RECRUITING

Outcomes

Primary Outcomes

Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system.

Time frame: 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.

Time frame: 7 days

Secondary Outcomes

Procedure time

Total procedure time.

Time frame: 1 day

Number of MRI scans

Number of MRI scans needed to complete the procedure, and size and depth of target will be recorded.

Time frame: 1 day

Clinical impressions of the system use and utility

The operator will complete a usability form that captures ease of use using the Likert scale.

Time frame: 1 Day

Central Contacts

Emily Leibold, BSE

CONTACT

202-476-5522 eleibold@childrensnational.org

Data from ClinicalTrials.gov

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