Augmented Reality For MRI-Guided Interventions

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Children's National

Status

Enrolling

Conditions

Diagnosis
Image Guided Needle Biopsy
Infections
Pain

Treatments

Device: Augmented Reality System

Study type

Interventional

Funder types

Other

Identifiers

NCT06224933
STUDY00000648

Details and patient eligibility

About

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

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

3 to 21 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Patients Undergoing Augmented Reality Image-Guided Needle Procedures
Experimental group
Description:
Patients 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.
Treatment:
Device: Augmented Reality System

Trial contacts and locations

1

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Central trial contact

Emily Leibold, BSE

Data sourced from clinicaltrials.gov

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