NCT05340244

GE CVUS Device Evaluation

GE Cardiovascular Ultrasound Device Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-07-26
• Completion: 2022-07-26
• First posted: 2022-04-22
• Last updated: 2023-01-10
• Results posted: 2022-11-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study