GE CVUS Device Evaluation

Echocardiography Clinical Trial

Official title:

GE Cardiovascular Ultrasound Device Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05340244
• Other study ID #: 217021760
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: July 26, 2022

Study information

• Verified date: December 2022
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 26, 2022
• Est. primary completion date: July 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Echocardiography

Intervention

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.

Locations

Country	Name	City	State
United States	The Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Primary	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.
Primary	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.