GE CVUS Device Evaluation

GE Cardiovascular Ultrasound Device Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Echocardiography
• Intervention / Treatment: Device: Investigational ultrasound exam

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • The Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Arm 1: Experimental

Device: Investigational ultrasound exam; 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.

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Safety Events	The number of adverse events will be reported. No clinical efficacy endpoints will be assessed.	The total number of adverse events will be reported. Subjects were monitored for adverse events throughout the duration (start to conclusion) of each investigational ultrasound exam, an average of 15 minutes per subject.
Number of Device Issues	The number of device issues will be reported. No clinical efficacy endpoints will be assessed.	The total number of device issues will be reported. Study staff monitored for device issues throughout the duration (start to conclusion) of each investigational ultrasound exam, an average of 15 minutes per subject.

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): July 26, 2022
• Study Completion (Actual): July 26, 2022

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Transesophageal Echocardiography; Transthoracic Echocardiography
• Other Study ID Numbers: 217021760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes