What is this study trying to find out about echocardiography?

This study is evaluating a new diagnostic ultrasound system for heart imaging during echocardiography. Researchers want to understand how well the investigational device works compared to current ultrasound machines and whether it is safe and easy to use. The trial is sponsored by GE Healthcare to support improved heart imaging techniques.

Who may be eligible for this echocardiography clinical trial?

Adults aged 18 years or older who need transesophageal echocardiography (TEE) as part of their medical care may be eligible. The study is open to all genders but excludes pregnant women and those with certain upper digestive tract conditions or emergencies. Please review eligibility criteria for more details.

Is there any cost to participate in this echocardiography clinical trial?

Study-related care, including the use of the investigational ultrasound device and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect their care to be supported without extra charges related to the study.

Actively Recruiting

Age: 18Years +

All Genders

ID07066449

Evaluation of the Vivid Pioneer Diagnostic Ultrasound System for Adults Undergoing Transesophageal Echocardiography

Led by GE Healthcare · Updated on 2025-09-19

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the clinical performance of the Vivid Pioneer Diagnostic Ultrasound System in adults who need transesophageal echocardiography TEE as part of their medical care. The study focuses on assessing the quality, usability, safety, and stability of this investigational ultrasound device compared to existing commercial cardiac ultrasound systems. It is an observational study sponsored by GE Healthcare, designed to support current clinical standards without affecting patient treatment timing. Participants will first undergo transthoracic echocardiography TTE using the investigational device. Then, after being anesthetized, they will receive the standard transesophageal echocardiography TEE procedure. Following the investigational device scan, the probe will be switched to a commercial ultrasound device for intraoperative guidance to ensure no delay in diagnosis or treatment. Researchers will evaluate the systems overall operation, image quality, user interface, workflow, and safety. During the study, investigators will complete a user feedback questionnaire covering the devices performance and functionality. Outcome measures include system operation, reliability, operability, and image quality, rated on a five-grade scale from Excellent to Very Bad. The study period extends from enrollment through the first day of scanning. Participants will be monitored for device safety and stability throughout their involvement, which lasts up to one day post-enrollment.

CONDITIONS

Brief Title

Clinical Performance Evaluation of a Diagnostic Ultrasound System

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults 18 years or older with the ability to consent
Required to undergo intraoperative transesophageal echocardiography (TEE) following clinical standards
Agree to participate and have signed the informed consent form

You will not qualify if you...

Previously enrolled in this study or participating in other clinical trials
Having a medical emergency requiring urgent treatment
Pregnant females
Having any absolute or relative contraindications to TEE, including but not limited to active upper gastrointestinal bleeding, esophageal disease, recent esophageal surgery, clotting disorders, poor cardiopulmonary function, or airway damage
Any other condition that the investigator believes disqualifies participation

Research Team

Juan Zhang

Zhihui Z Zhang, Zhi

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