GE CVUS Device Evaluation

Status Completed

Clinical Trial Summary

The purpose of the study is to collect user feedback on the Vivid E95 ultrasound system and probes during clinical procedures on the device's intended population in order to optimize the device.

Clinical Trial Description

The purpose of the study is to collect user feedback on the Vivid E95 ultrasound system and probes during clinical procedures on the device's intended population in order to optimize the device. The primary objective of this study is to collect user feedback and de-identified images from the Vivid E95 ultrasound system and probes in TTE and TEE exams in a clinical setting. User feedback will include workflow, performance, user preference, image quality, device features, and open-ended feedback. The safety objective of this study is to collect safety information, including type and number of adverse events and device issues. This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in the United States. This study is not intended to support a comparative claim or test any hypotheses, such as superiority or non-inferiority. No clinical efficacy endpoints will be assessed. ;

Study Design

Related Conditions & MeSH terms

Echocardiography

Clinical Trial Details

NCT number	NCT05340244
Study type	Interventional
Source	GE Healthcare
Contact
Status	Completed
Phase	N/A
Start date	June 1, 2022
Completion date	July 26, 2022

View Details

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