Augmented Reality Ultrasound Guidance
HoloUS
HoloUS: Augmented Reality Visualization of Live Ultrasound Images Using HoloLens for Ultrasound-guided Procedures
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2022
CompletedFirst Submitted
Initial submission to the registry
July 18, 2023
CompletedFirst Posted
Study publicly available on registry
July 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJuly 3, 2024
July 1, 2024
2.8 years
July 18, 2023
July 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Task completion time
This outcome measure examines if the use of augmented reality leads to faster procedure.
The 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 first
Secondary Outcomes (2)
Number of attempts
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 first.
Number of head adjustments
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 first.
Study Arms (1)
HoloUS app for ultrasound visualization
EXPERIMENTALThis is a single-arm study. Each study participant will evaluate HoloUS app and serve as their own control.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Any previous experience or training using the current version of the HoloUS app on the HoloLens.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Raj Shekhar, PhD
Children's National Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2023
First Posted
July 28, 2023
Study Start
March 11, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
July 3, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share