InfectionsNCT06224933
Augmented Reality For MRI-Guided Interventions
A study testing Augmented Reality System in people with Infections and Pain, run by Children's National Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Pain, Diagnosis
- What is being tested?
- Augmented Reality System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Karun Sharma, MD, PhD, 202-476-3791, kvsharma@childrensnational.org
Emily Leibold, BSE, 202-476-5522, eleibold@childrensnational.org
About this study
Official title: Augmented Reality Real-Time Guidance for MRI-Guided Interventions
The purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing MRI-Guided needle procedures.
Read the 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.
- Conditions
- Infections, Pain, Diagnosis
- Being tested
- Augmented Reality System
- Medical subject headings
- Infections, Pain, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Augmented Reality Image-Guided Needle Procedures | Experimental | 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. Receives: Device: Augmented Reality System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system.
Measured: 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.
Measured: 7 days
Secondary outcomes (3)
Procedure time
Total procedure time.
Measured: 1 day
Number of MRI scans
Number of MRI scans needed to complete the procedure, and size and depth of target will be recorded.
Measured: 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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start6 Feb 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karun Sharma MD, Children's National Research Institute
- Investigators
- Karun Sharma, MD, PhD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224933
- Sponsor's protocol ID
- STUDY00000648
- Status last verified
- Aug 2025
- First submitted
- 22 Nov 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality Real-Time Guidance for MRI-Guided Interventions
- ClinicalTrials.gov ID
- NCT06224933
- Acronym / sponsor ID
- STUDY00000648
- Conditions
- Infections, Pain, Diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Augmented Reality Image-Guided Needle Procedures | Experimental | Device: Augmented Reality SystemPatients 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. |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Reality SystemSubjects 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. | Device | Patients Undergoing Augmented Reality Image-Guided Needle Procedures |
Primary outcome
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
3 secondary outcomes
Procedure time
Time frame: 1 day
Number of MRI scans
Time frame: 1 day
Clinical impressions of the system use and utility
Time frame: 1 Day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karun Sharma, MD, PhD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality System in people with Infections and Pain, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Leibold, BSE (202-476-5522, eleibold@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.