Recruiting

Augmented Reality

Sponsor:

Children's National Research Institute

Code:

NCT05964439

Conditions

Paracentesis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

HoloUS app for ultrasound visualization

Study Details

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.

Conditions

Paracentesis

Study ID

NCT05964439

Start date

Mar 11, 2022

Status verified date

Jul, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

44 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: HoloUS app for ultrasound visualization

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

Interventions

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.

Primary outcome measure

  • Task completion time [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Raj Shekhar, PhD

202-476-1201rshekhar@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington, District of Columbia, United States, 20010

More Information

Sponsor

Children's National Research Institute

Last update posted

Jul 3, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2024-07-03.