Study for the Assessment of the Quality of Echocardiographic Clips.

Status Completed

Clinical Trial Summary

This study main objective is to evaluate the safety and efficacy of the UltraSight AI Guidance software. The investigational product is a software that guides the user to capture a high quality ultrasound image. The study will include healthcare professionals, not specialized in echocardiography, who will perform echocardiography by using UltraSight AI Guidance software, on subjects in the medical centers cardiac units.

Clinical Trial Description

This pivotal study is a multi-center, multi-reader multi-case (MRMC) study, designed to assess the quality of the clips obtained by novice users when using the UltraSight AI Guidance software. Prior to the study start, there will be a pre-study training phase for training the novice users. During the study, eligible subject will undergo the echocardiography examination twice on a single study visit (same day): once by one of the novice users when using the UltraSight AI Guidance software, and once by an expert sonographer without the aid of the software. Each novice user will perform the examination on at least 20 subjects (with the aim that the number of examinations by each novice will be similar). All examinations will be sent to multiple Board certified cardiologists for their quality evaluations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05090748
Study type	Observational
Source	UltraSight
Contact
Status	Completed
Phase
Start date	May 15, 2022
Completion date	August 31, 2022

View Details

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