GE CVUS Device Evaluation

Not Applicable

Completed

Brief 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Has a clinical indication for a TEE and/or TTE procedure with an ultrasound device
Has a weight of at least 5kg
Are able and willing to comply with study procedures
If less than 7 years old, has a parent or legally authorized representative able and willing to provide written consent to participate
If 7-17 years old, are able and willing to provide written assent to participate AND have a parent or legally authorized representative able and willing to provide written consent to participate
If 18 years old or older, are able and willing to provide written consent to participate

Exclusion Criteria

Pregnant or suspected to be pregnant based on the opinion of a clinician investigator
Expected to be at increased risk due to study participation (e.g. due to sensitivities, relative or absolute contraindication to TEE), in the opinion of a clinician investigator
Previously participated in this study or are enrolled in another research study that could be expected to interfere with participation in study procedures
History of esophageal surgery or known vascular ring

Arm && Interventions

Group	Intervention	Description
Arm 1: Experimental	Investigational ultrasound exam	-

Primary Outcome Measures

Name	Time	Method
Number of De-identified Images	The total number of images collected will be reported. Multiple images are collected from each subject and the protocol does not require images to be collected at specific points in time. The device was used on each subject for about 15 minutes.	The primary objective of this study is to collect de-identified images from the investigational ultrasound system in TTE and TEE exams in a clinical setting.
Number of User Feedback Surveys	The total number of User Surveys will be reported. Surveys capture feedback from the device user across multiple subjects. The protocol did not require surveys be collected at specific timepoints. The device was used on each subject for about 15 minutes.	The primary objective of this study is to collect user feedback from the investigational ultrasound system in TTE and TEE exams in a clinical setting. User Surveys consist of Likert scales and qualitative feedback and this data will not follow a statistical analysis plan.

Secondary Outcome Measures