Augmented Reality For MRI-Guided Interventions

Pain Clinical Trial

Official title:

Augmented Reality Real-Time Guidance for MRI-Guided Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06224933
• Other study ID #: STUDY00000648
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: January 2024
• Source: Children's National Research Institute
• Contact: Emily Leibold, BSE
• Phone: 202-476-5522
• Email: eleibold[@]childrensnational.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diagnosis
• Infections
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system.		1 day
Primary	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	Procedure time	Total procedure time.	1 day
Secondary	Number of MRI scans	Number of MRI scans needed to complete the procedure, and size and depth of target will be recorded.	1 day
Secondary	Clinical impressions of the system use and utility	The operator will complete a usability form that captures ease of use using the Likert scale.	1 Day