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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Ultrasound-guided procedure using AR/VR technology?

Research shows that using augmented reality (AR) with ultrasound can improve the accuracy of procedures like needle biopsies and surgical navigation. For example, AR guidance led to more precise needle placement in biopsies and helped surgeons better visualize tumors during breast cancer surgery, which can lead to more accurate and effective treatments. ^{1 2 3 4 5}

How does the AR/VR technology for ultrasound-guided procedures differ from other treatments?

This treatment uses augmented reality (AR) technology, like the HoloLens headset, to overlay live ultrasound images directly onto the patient's anatomy, allowing for real-time, in-situ visualization. This approach enhances the practitioner's ability to perform precise procedures by providing a more intuitive and direct view compared to traditional methods that require interpreting images on separate monitors. ^{1 3 6 7 8}

What is the purpose of this trial?

The study seeks to assess the efficacy of incorporating augmented reality (AR) or virtual reality (VR) technology into ultrasound-guided medical procedures such as regional anesthesia and line placement. By utilizing AR/VR devices, the investigators will improve the ergonomics when using ultrasound to guide procedures. The aims are to enhance visualization of anatomical structures and improve procedural accuracy for clinicians. The study aims to evaluate the feasibility, and effectiveness of integrating AR/VR technology into ultrasound-guided procedures, with the ultimate goal of improving patient outcomes.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

UltrARsound: in situ visualization of live ultrasound images using HoloLens 2. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Augmented reality guidance for needle biopsies: an initial randomized, controlled trial in phantoms. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

In Situ Visualization for 3D Ultrasound-Guided Interventions with Augmented Reality Headset. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Image guidance of breast cancer surgery using 3-D ultrasound images and augmented reality visualization. [2016]

5. Germany pubmed.ncbi.nlm.nih.gov

Augmented reality surgical navigation with ultrasound-assisted registration for pedicle screw placement: a pilot study. [2018]

6. Greece pubmed.ncbi.nlm.nih.gov

Optical See-through Head-mounted Display (OST-HMD)-assisted Needle Biopsy for Breast Tumor: A Technical Innovation. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

HoloUS: Augmented reality visualization of live ultrasound images using HoloLens for ultrasound-guided procedures. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided interventions with augmented reality in situ visualisation: a proof-of-mechanism phantom study. [2021]