AR/VR Technology for Ultrasound-Guided Procedures

Overseen By Jean-Louis Horn, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Pregnancy, Incarceration, BMI >35

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: During the procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether augmented reality (AR) or virtual reality (VR) can enhance the effectiveness of ultrasound-guided medical procedures. The researchers aim to determine if these technologies improve doctors' visualization and accuracy, potentially leading to better patient outcomes. The focus is on procedures such as regional anesthesia and line placement. Adults requiring ultrasound-guided procedures with a common physical status (ASA I, II, or III) may be suitable candidates for this trial.

As an unphased trial, this study offers patients the chance to contribute to innovative research that could improve medical procedures in the future.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this AR/VR technology is safe for ultrasound-guided procedures?

Research has shown that augmented reality (AR) and virtual reality (VR) in medical procedures are generally safe and well-received. These technologies have been successfully applied in surgical practice and patient education. The FDA supports the development of AR and VR, indicating their safety when used correctly.

For ultrasound-guided procedures, specific data on negative effects from AR/VR is lacking. However, their current use in healthcare suggests they are not harmful. The aim is to enhance the experience for both patients and doctors. While this is promising, it is important to note that the study is still exploring the optimal use of these technologies in such procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using AR/VR technology for ultrasound-guided procedures because it brings a groundbreaking level of precision and visualization. Unlike traditional ultrasound-guided methods, which rely heavily on the practitioner's skill and experience, AR/VR technology can overlay digital images onto the real-world ultrasound view. This enhanced visualization helps to improve accuracy and potentially reduce procedure time and errors. With these advancements, clinicians can perform procedures more efficiently and safely, providing better outcomes for patients.

What evidence suggests that AR/VR technology is effective for ultrasound-guided procedures?

Research shows that augmented reality (AR) with ultrasound can enhance the accuracy of procedures like needle biopsies and surgical navigation. In this trial, participants will undergo ultrasound-guided procedures using AR/VR technology. AR technology has helped trainees perform better and feel less mentally strained during procedures such as placing central venous catheters with ultrasound. Studies also suggest that displaying live ultrasound images through AR devices, like smart glasses, aids in procedures involving blood vessel access. Additionally, AR improves comfort by enhancing depth perception and reducing eye strain for clinicians. These findings support the potential for AR/VR technology in ultrasound-guided procedures to improve patient outcomes. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for clinicians performing ultrasound-guided medical procedures like regional anesthesia or line placement. It's designed to see if using AR/VR technology can help them do their jobs better by improving how they see and interact with patient anatomy.

Inclusion Criteria

I am an adult with a health status classified as ASA I, II, or III.

Exclusion Criteria

Pregnancy

Incarceration

My BMI is over 35.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ultrasound-guided medical procedures using AR/VR technology to enhance precision and accuracy

During the procedure

1 visit (in-person)

Follow-up

Participants are monitored for post-operative outcomes such as pain scores and opioid consumption

12 hours

Clinician Feedback

Clinicians provide feedback on the usability and effectiveness of AR/VR technology

Within 24 hours of block completion

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound-guided procedure using AR/VR technology

Trial Overview The study tests the use of augmented reality (AR) and virtual reality (VR) in ultrasound-guided medical procedures. The goal is to determine if these technologies make it easier for doctors to perform these procedures accurately, which could lead to better outcomes for patients.

How Is the Trial Designed?

Group I: AR/VR Experimental Treatment 1 Intervention

AR/VR technology for ultrasound-guided procedures.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

In a randomized controlled trial involving 50 core biopsies of breast phantoms, biopsies guided by a 3D Augmented Reality (AR) system showed significantly greater accuracy compared to standard ultrasound-guided methods, with a mean deviation of 1.62 mm versus 2.48 mm (p<0.02).

The study indicates that AR guidance can enhance the precision of needle biopsies, potentially leading to better clinical outcomes in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented reality guidance for needle biopsies: an initial randomized, controlled trial in phantoms. Rosenthal, M., State, A., Lee, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11429828/

Augmented reality visualization for ultrasound-guided ... AR technology helped improve trainee performance and reduced cognitive load during ultrasound-guided CVC placement. These findings support the application of AR ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301562923002259

Assessing the Effect of Augmented Reality on Procedural ... Conclusion. Augmented reality display of live ultrasound images using the Microsoft HoloLens 2 smart glasses is a useful tool for vascular access procedures.

3. withpower.com withpower.com/trial/phase-virtual-reality-8-2025-8a17b

AR/VR Technology for Ultrasound-Guided Procedures Research shows that using augmented reality (AR) with ultrasound can improve the accuracy of procedures like needle biopsies and surgical navigation. For ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jcu.23840

The use of virtual reality and augmented ... This narrative review examines the use of IVR and AR in ultrasound education, evaluating their effectiveness compared to traditional methods.

5. liebertpub.com liebertpub.com/doi/10.1177/29941520251377069

Augmented Reality in Interventional Radiology: A Review ... Current literature suggests improved ergonomics, mainly enhanced depth perception, decreased eye movement/fatigue, and decreased cybersickness ...

6. sciencedirect.com sciencedirect.com/science/article/pii/B9780443364341000045

Augmented reality (AR) and virtual reality (VR) ... It explores the various applications of AR and VR, including surgical simulations, rehabilitation therapies, patient education, and mental ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11528804/

Immersive Technologies in Healthcare - PubMed Central - NIH This review aims to explore the current applications of VR and AR in healthcare, particularly focusing on their roles in enhancing patient care and medical ...

8. fda.gov fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices

Augmented Reality and Virtual Reality in Medical Devices The FDA encourages the development of innovative, safe, and effective medical devices, including devices that incorporate augmented reality and virtual reality ...

9. bmcmededuc.biomedcentral.com bmcmededuc.biomedcentral.com/articles/10.1186/s12909-024-05998-8

Augmented reality visualization for ultrasound-guided ... The findings indicate that videos, virtual reality (VR), and AR elicited more positive emotional responses in females, compared to males.