GE CVUS Device Evaluation

NCT ID: NCT05340244

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-07-26

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.

Conditions

Echocardiography

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm 1: Experimental

Group Type: EXPERIMENTAL

Investigational ultrasound exam

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Children's Mercy Hospital

Kansas City, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

217021760

Identifier Type: -

Identifier Source: org_study_id