Augmented Reality Ultrasound Guidance

NCT ID: NCT05964439

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-11

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Paracentesis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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HoloUS app for ultrasound visualization

This is a single-arm study. Each study participant will evaluate HoloUS app and serve as their own control.

Group Type EXPERIMENTAL

HoloUS app for ultrasound visualization

Intervention Type DEVICE

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.

Interventions

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HoloUS 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's National Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raj Shekhar, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

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Children's National Hospital

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Raj Shekhar, PhD

Role: CONTACT

202-476-1201

Facility Contacts

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Raj Shekhar, PhD

Role: primary

Other Identifiers

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Pro00016558

Identifier Type: -

Identifier Source: org_study_id

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