Recruiting

Augmented Reality

Sponsor:

Children's National Research Institute

Code:

NCT06224933

Conditions

Infections

Pain

Diagnosis

Eligibility Criteria

Sex: All

Age: 3 - 21

Healthy Volunteers: Accepted

Interventions

Augmented Reality System

Study Details

Brief 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.

Conditions

Infections

Pain

Diagnosis

Study ID

NCT06224933

Start date

Feb 6, 2024

Status verified date

Aug, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 21

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Patients Undergoing Augmented Reality Image-Guided Needle Procedures

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.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Emily Leibold, BSE

202-476-5522eleibold@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Karun Sharma, MD, PhD

202-476-3791kvsharma@childrensnational.org

Emily Leibold, BSE

202-476-5522eleibold@childrensnational.org

Principal Investigator:

Karun Sharma, MD/PhD

More Information

Sponsor

Children's National Research Institute

Last update posted

Sep 5, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2025-09-05.