GE CVUS Device Evaluation

NCT05340244 | Completed Results FDA Device

• 1 other identifier: 217021760
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Echocardiography

Keywords

Transthoracic Echocardiography; Transesophageal Echocardiography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of Safety Events

  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 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.

Study Arms (1)

Arm 1: Experimental

EXPERIMENTAL

Device: Investigational ultrasound exam

Interventions

Investigational ultrasound exam DEVICE

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.

Arm 1: Experimental

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Results Point of Contact

• Title: Tracy Grzendzielewski
• Organization: GE Healthcare

tracy.grzendzielewski@ge.com

414-218-6167

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in the United States.

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 22, 2022
• Study Start: June 1, 2022
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: January 10, 2023
• Results First Posted: November 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)