Viewing Study NCT05964439



Ignite Creation Date: 2024-05-06 @ 7:18 PM
Last Modification Date: 2024-10-26 @ 3:04 PM
Study NCT ID: NCT05964439
Status: RECRUITING
Last Update Posted: 2024-07-03
First Post: 2023-07-18

Brief Title: Augmented Reality Ultrasound Guidance
Sponsor: Childrens National Research Institute
Organization: Childrens National Research Institute

Study Overview

Official Title: HoloUS Augmented Reality Visualization of Live Ultrasound Images Using HoloLens for Ultrasound-guided Procedures
Status: RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HoloUS
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
Detailed Description: 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 eg 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 studys 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 practitioners 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None