Augmented RealityNCT06550193
Augmented Reality/Virtual Reality (AR/VR) for Ultrasound-guided Medical Procedures
A study testing Ultrasound-guided procedure using AR/VR technology in people with Augmented Reality and Virtual Reality, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Augmented Reality, Virtual Reality
- What is being tested?
- Ultrasound-guided procedure using AR/VR technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to 31 Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients presenting for ultrasound-guided procedures, with ASA physical status I, II, or III.
Who cannot join
- pregnancy
- incarceration
- BMI >35
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
Stanford Hospital and Clinics
Stanford, California, 94305
Ksenia Kasimova, MD, 6507889458, kasimova@stanford.edu
Jean Louis-Horn, MD
About this study
Official title: The Use of Augmented Reality (AR) or Virtual Reality (VR) to Enhance the Precision and Accuracy of Ultrasound-guided Medical Procedures
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.
Read the detailed description
The investigators aim to learn several key insights from this study. Firstly, they hope to determine the extent to which augmented reality (AR) or virtual reality (VR) technology can enhance the precision and accuracy of ultrasound-guided medical procedures, such as regional anesthesia and line placement. This includes evaluating whether AR/VR visualization leads to improved needle placement and reduced complication rates.
Furthermore, the investigators aim to evaluate the usability and acceptance of AR/VR technology among clinicians, considering factors such as user experience, comfort, and integration with existing workflow processes.
The importance of this new knowledge lies in its potential to improve medical practice by leveraging cutting-edge technology to improve patient outcomes and expand access to quality healthcare globally. If AR/VR proves to be effective in enhancing procedural accuracy, it could lead to significant advancements in healthcare delivery, particularly in underserved communities and resource-limited settings by leveraging remote care. Additionally, insights gained from this study could inform the development of future AI assisted AR/VR applications in medicine, driving innovation and improving the standard of care across various medical specialties.
- Conditions
- Augmented Reality, Virtual Reality
- Being tested
- Ultrasound-guided procedure using AR/VR technology
- Keywords
- ultrasound-guided procedure, nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided procedure using AR/VR technologyDevice
Participants will receive the intervention, which involves utilizing AR/VR technology during ultrasound-guided procedures (e.g., regional anesthesia, line placement). All participants will receive standard pre- and post-block or line care as they normally would for the ultrasound-guided procedure.
| Study group | Role | What they receive |
|---|---|---|
| AR/VR | Experimental | AR/VR technology for ultrasound-guided procedures. Receives: Device: Ultrasound-guided procedure using AR/VR technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure success rate (Primary Block)
Document the block result in pre-op, if feasible, or PACU by testing sensory (cold spray) and motor function on all nerves covered by the block
Measured: Document the block result pre-operatively (at least 30 min following block completion), or within one hour upon arriving to PACU
Post-operative opioid consumption
Morphine milligram equivalents (MME) will be measured post-operatively
Measured: 12 hours after surgery
Post-operative pain scores
Trend pain scores on 11-point NRS scale (from 0 to 10) following the procedure
Measured: 12 hours after surgery
Secondary outcomes (4)
Clinician satisfaction
A short survey will be utilized to gather data on clinicians' perceptions of the ease of use, effectiveness, and overall experience with AR/VR tools compared to traditional methods.
Measured: Within 24 hours of block completion
Procedure duration
Time of procedure from initial needle insertion to needle removal will be calculated
Measured: During the procedure
Needle pass/redirection
The number of times a clinician must remove the needle from the patient completely and reattempt will be calculated.
Measured: During the procedure
Needle visualisation
A subjective score will be assessed on a short survey to clinicians.
Measured: Within 24 hours of block completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start30 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Augmented RealityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the intervention, which involves utilizing AR/VR technology during ultrasound-guided procedures.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Louis Horn, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550193
- Sponsor's protocol ID
- 75204
- Status last verified
- Apr 2026
- First submitted
- 16 Jul 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Augmented Reality (AR) or Virtual Reality (VR) to Enhance the Precision and Accuracy of Ultrasound-guided Medical Procedures
- ClinicalTrials.gov ID
- NCT06550193
- Acronym / sponsor ID
- 75204
- Conditions
- Augmented Reality, Virtual Reality
- Keywords
- ultrasound-guided procedure, nerve block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Aug 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 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.
Detailed description
The investigators aim to learn several key insights from this study. Firstly, they hope to determine the extent to which augmented reality (AR) or virtual reality (VR) technology can enhance the precision and accuracy of ultrasound-guided medical procedures, such as regional anesthesia and line placement. This includes evaluating whether AR/VR visualization leads to improved needle placement and reduced complication rates.
Furthermore, the investigators aim to evaluate the usability and acceptance of AR/VR technology among clinicians, considering factors such as user experience, comfort, and integration with existing workflow processes.
The importance of this new knowledge lies in its potential to improve medical practice by leveraging cutting-edge technology to improve patient outcomes and expand access to quality healthcare globally. If AR/VR proves to be effective in enhancing procedural accuracy, it could lead to significant advancements in healthcare delivery, particularly in underserved communities and resource-limited settings by leveraging remote care. Additionally, insights gained from this study could inform the development of future AI assisted AR/VR applications in medicine, driving innovation and improving the standard of care across various medical specialties.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the intervention, which involves utilizing AR/VR technology during ultrasound-guided procedures.
| Arm | Type | Receives |
|---|---|---|
| AR/VR | Experimental | Device: Ultrasound-guided procedure using AR/VR technologyAR/VR technology for ultrasound-guided procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients presenting for ultrasound-guided procedures, with ASA physical status I, II, or III.
Key exclusion criteria (3 listed)
- pregnancy
- incarceration
- BMI >35
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 |
|---|---|---|
| Ultrasound-guided procedure using AR/VR technologyParticipants will receive the intervention, which involves utilizing AR/VR technology during ultrasound-guided procedures (e.g., regional anesthesia, line placement). All participants will receive standard pre- and post-block or line care as they normally would for the ultrasound-guided procedure. | Device | AR/VR |
Primary outcome
Procedure success rate (Primary Block)
Time frame: Document the block result pre-operatively (at least 30 min following block completion), or within one hour upon arriving to PACU
Document the block result in pre-op, if feasible, or PACU by testing sensory (cold spray) and motor function on all nerves covered by the block
Post-operative opioid consumption
Time frame: 12 hours after surgery
Morphine milligram equivalents (MME) will be measured post-operatively
Post-operative pain scores
Time frame: 12 hours after surgery
Trend pain scores on 11-point NRS scale (from 0 to 10) following the procedure
4 secondary outcomes
Clinician satisfaction
Time frame: Within 24 hours of block completion
Procedure duration
Time frame: During the procedure
Needle pass/redirection
Time frame: During the procedure
Needle visualisation
Time frame: Within 24 hours of block completion
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 7 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided procedure using AR/VR technology in people with Augmented Reality and Virtual Reality, run by Stanford University 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 1 inclusion and 3 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 7 May 2026. 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 Jean-Louis Horn, MD (5033811645, hornj@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure success rate (Primary Block) (time frame: Document the block result pre-operatively (at least 30 min following block completion), or within one hour upon arriving to PACU). The study lists 3 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 7 May 2026.