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Augmented Reality Ultrasound Guidance

HoloUS: Augmented Reality Visualization of Live Ultrasound Images Using HoloLens for Ultrasound-guided Procedures

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05964439
Acronym
HoloUS
Enrollment
44
Registered
2023-07-28
Start date
2022-03-11
Completion date
2024-12-31
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paracentesis

Brief summary

Many medical procedures are done with the aid of ultrasound imaging, but they remain difficult to learn and perform. This study will use augmented reality technology for making these procedures potentially more intuitive, easier, more precise, and safer.

Detailed description

Minimally invasive ultrasound-guided procedures are a mainstay of modern medicine and the number of such procedures continues to grow. Safe, efficient, and precise execution of these procedures requires a clear visualization of the target anatomy and the interventional device (e.g., a needle). While sustained advances in ultrasound technology have led to greatly enhanced visualization of the anatomy and the needle with high image quality, hand-eye coordination of the practitioner continues to be a challenge. In order to properly position the interventional device, the practitioner must alternate their attention between observing the patient, advancing the needle, and viewing the ultrasound image on a separate screen. This study's long-term goal is to develop an advanced visualization platform for ultrasound-guided procedures to overcome this challenge by greatly simplifying hand-eye coordination. The proposed platform will be developed using the latest advances in the augmented reality (AR) technology. Through wearable, see-through AR glasses, the platform will create a virtual display placed in the practitioner's field of view to show live ultrasound images, registered with the transducer and the patient, in the form of a hologram. The investigative team hypothesizes that such visualization will reduce the time of procedure by 20%. This study is aimed providing the practitioner a more intuitive and efficient platform to perform ultrasound-guided procedures and demonstrating improved efficiency through user studies.

Interventions

DEVICEHoloUS app for ultrasound visualization

Study participants will wear HoloLens see-through glasses and use the HoloUS app for ultrasound visualization in the conduct of a vascular access procedure in a phantom.

Sponsors

Children's National Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* Employees of the institution over 18 years. * Volunteers participants who provide oral consent. * For expert group, participants who have been trained to perform and are comfortable with point-of-care ultrasound procedures (e.g., residents, fellows, attendings, vascular access PAs/NPs).

Exclusion criteria

* Any previous experience or training using the current version of the HoloUS app on the HoloLens.

Design outcomes

Primary

MeasureTime frameDescription
Task completion timeThe total time from when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred firstThis outcome measure examines if the use of augmented reality leads to faster procedure.

Secondary

MeasureTime frameDescription
Number of head adjustmentsFrom when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first.Number of times the user moved or turned their head from its baseline position at the start of the procedure until task completion.
Number of attemptsFrom when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first.Number of times the user needed to successfully withdraw fluid from the vessel.

Countries

United States

Contacts

Primary ContactRaj Shekhar, PhD
rshekhar@childrensnational.org202-476-1201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026