GE CVUS Device Evaluation

Study Overview
=================
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.

Official Title
-----------------
GE Cardiovascular Ultrasound Device Evaluation

Conditions
-----------------
Echocardiography

Intervention / Treatment
-----------------
* Device: Investigational ultrasound exam


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in the United States.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Experimental<br> | Device: Investigational ultrasound exam<br>* Eligible subjects will be enrolled into the study and positioned for their ultrasound exam. Standard clinical practice procedures will be followed using the standard of care device at the site to complete the clinically indicated exams. After the clinically indicated exam, portions of the TTE and/or TEE exam will be repeated with the investigational ultrasound device.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of User Feedback Surveys | 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. | 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. | 
| Number of De-identified Images | 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. | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transthoracic Echocardiography, Transesophageal Echocardiography