Augmented Reality Ultrasound Guidance for Paracentesis

(HoloUS Trial)

Overseen By Raj Shekhar, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Experience with HoloUS app

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 10 minutes per procedure

44 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Raj Shekhar, PhD

Principal Investigator

Children's National Research Institute

Eligibility Criteria

This trial is for employees and volunteers over 18 at the institution who consent to participate. It's specifically for those trained in point-of-care ultrasound procedures, like residents or vascular access professionals. People with prior experience using the HoloUS app on HoloLens are excluded.

Inclusion Criteria

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)

Volunteers participants who provide oral consent

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants evaluate the HoloUS app for ultrasound visualization during procedures

10 minutes per procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after using the HoloUS app

4 weeks

Treatment Details

Interventions

• HoloUS app

Trial Overview The study is testing an augmented reality app called HoloUS that works with ultrasound imaging during medical procedures. The goal is to see if it makes these procedures easier, more accurate, and safer by providing a more intuitive visual guide.

Participant Groups

Group I: HoloUS app for ultrasound visualization Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+