Augmented Reality Ultrasound Guidance for Paracentesis

(HoloUS Trial)

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called HoloUS, which uses augmented reality to simplify and improve the safety of ultrasound-guided procedures. The goal is to determine if this technology can make these procedures more intuitive and precise. The trial seeks volunteers from the institution who are already skilled in performing ultrasound procedures. Participants should not have used the current version of the HoloUS app. As an unphased trial, this study offers a unique opportunity to contribute to innovative technology that could enhance medical procedures.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this augmented reality technology is safe for ultrasound guidance?

Research has shown that the HoloUS app, which uses augmented reality for ultrasound guidance, has been tested in various settings. It improves user experience and enhances hand-eye coordination, making procedures like paracentesis (removing fluid from the belly) easier and more accurate. Studies have not reported specific safety issues or negative effects. The trial's "Not Applicable" phase label likely indicates a focus on usability rather than testing a new drug, suggesting that the treatment is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The HoloUS app is unique because it uses augmented reality to guide ultrasound imaging for paracentesis, making the procedure more intuitive and potentially more accurate. Unlike traditional ultrasound guidance, which can be challenging to interpret in real-time, the HoloUS app overlays digital imagery directly onto the patient's body, helping clinicians visualize the anatomy with greater clarity. Researchers are excited about this technology because it could improve the precision and safety of paracentesis, reducing the risk of complications and enhancing patient outcomes.

What evidence suggests that the HoloUS app is effective for ultrasound-guided procedures?

Research has shown that the HoloUS app, which participants in this trial will evaluate, enhances the use of ultrasound imaging. One study found that it aids users by displaying ultrasound images directly in front of them, eliminating the need to look back and forth between the body and a screen. This feature simplifies procedures like removing fluid from the abdomen, making them easier and more accurate. Another study found that augmented reality can increase the precision of ultrasound-guided procedures. Overall, early evidence suggests that the HoloUS app could simplify these medical tasks and potentially improve safety. ^{1 2 5 6 7}

Who Is on the Research Team?

Raj Shekhar, PhD

Principal Investigator

Children's National Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05964439

Study Details | NCT05964439 | Augmented Reality Ultrasound ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10658651/

Assessing the impact of augmented reality on procedural ... This is the first investigation of augmented reality-based ultrasound-guided vascular access using the second-generation HoloLens. It demonstrates equivalent ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34817764/

HoloUS: Augmented reality visualization of live ultrasound ... The HoloUS application was found to enhance user experience and simplify hand-eye coordination. By eliminating the need to alternately ...

4. clinconnect.io clinconnect.io/trials/NCT05964439

Augmented Reality Ultrasound Guidance (NCT05964439) This clinical trial is studying how augmented reality (AR) technology can improve ultrasound guidance during a procedure called paracentesis, which is used to ...

5. researchgate.net researchgate.net/publication/395922164_The_Development_and_Evaluation_of_a_Low-Cost_High-Fidelity_Ultrasound-Guided_Abdominal_Paracentesis_Simulator

The Development and Evaluation of a Low-Cost, High- ... This study aimed to compare the efficacy of ultrasound guided abdominal field blocks (USAFB) with port site infiltrations for post-operative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11393663/

Augmented reality for point-of-care ultrasound-guided ... This work builds upon our previous investigation of using a novel AR application, HoloUS, for ultrasound-guided venipuncture and aspiration tasks on a vascular ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07208071

Investigating the Utility of Augmented Reality Assistance for ... This study will investigate the benefits of augmented reality assistance on ultrasound-guided vascular access. Using the Microsoft HoloLens 2 ...