Actively Recruiting
Clinical Performance Evaluation of a Diagnostic Ultrasound System
Led by GE Healthcare · Updated on 2025-09-19
60
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Subjects who are required to undergo transesophageal echocardiography according to the current clinical practice standards will be eligible for enrollment. Subjects will be screened for enrollment in this study against the inclusion and exclusion criteria. After successful screening and enrollment of subjects, the investigators will first use the investigational device to conduct transthoracic echocardiography (TTE), followed by transesophageal echocardiography (TEE). TEE will be conducted after the subject has been anesthetized. To avoid any delay in diagnosis and treatment, after the scan with the investigational device is completed, the probe will be reserved and the console will be switched to the existing commercial cardiac diagnostic ultrasound device in the study site for intraoperative guidance. In the study, each investigator will evaluate the overall image quality, user interface, workflow, user preferences, product preset, and functions of the system, as well as the device's safety and stability and fill out a user feedback questionnaire provided by the Sponsor.
CONDITIONS
Official Title
Clinical Performance Evaluation of a Diagnostic Ultrasound System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years old or older with autonomous capacity
- Required to undergo intraoperative transesophageal echocardiography according to current clinical practice 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
- Have any medical emergency requiring urgent treatment
- Pregnant females
- Have absolute or relative contraindications to TEE such as upper digestive tract diseases (active hemorrhage, obstruction, esophageal tumor, lacerations, perforations, diverticula), changes in consciousness, history of cervical or mediastinal radiotherapy, recent esophageal surgery, esophageal varicosity, clotting disorders, cervical disease or injury, active esophagitis, gastrointestinal ulcers, hiatal hernia, poor cardiopulmonary function, airway damage, or pharyngeal space-occupying lesions
- Any other condition that investigators consider a reason not to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital, Nanjing Medical University
Nanjing, China
Actively Recruiting
Research Team
J
Juan Zhang
CONTACT
Z
Zhihui Z Zhang, Zhi
CONTACT
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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