Clinical trial NCT05340244: GE CVUS Device Evaluation
Official title: GE Cardiovascular Ultrasound Device Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Echocardiography
Keywords: Transthoracic Echocardiography
Transesophageal Echocardiography
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2022-04-22
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in the United States.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Number of User Feedback Surveys
timeFrame: 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.
measure: Number of De-identified Images
timeFrame: 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.
Secondary outcomes:
Other outcomes:
measure: Number of Safety Events
timeFrame: 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.
measure: Number of Device Issues
timeFrame: 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.
Locations:
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
Study officials:
References: