Actively Recruiting
Clinical Performance Evaluation of the Vivid Pioneer Diagnostic Ultrasound System
Led by GE Healthcare · Updated on 2025-09-19
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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 system's overall operation, image quality, user interface, workflow, and safety. During the study, investigators will complete a user feedback questionnaire covering the device's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
Participants undergo intraoperative transesophageal echocardiography (TEE) as part of the diagnostic evaluation using the ultrasound system.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital, Nanjing Medical University
Nanjing, China
Actively Recruiting
Research Team
J
Juan Zhang
Z
Zhihui Z Zhang, Zhi
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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