Clinical Performance Evaluation of a Diagnostic Ultrasound System

General Electric (GE)

Status: Enrolling

Conditions: Echocardiography

Study type: Observational

Funder types: Industry

Identifiers

NCT07066449

KY20250225-05

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults ≥ 18 years old, have autonomous capacity;
2. Subjects who are required to undergo intraoperative transesophageal echocardiography according to the current clinical practice standards;
3. Agree to participate in this study and have signed the subject Informed Consent Form.

Exclusion criteria

1. Subjects who have been previously enrolled in this study or are participating in other clinical trials;
2. Subjects with any medical emergency condition requiring urgent treatment;
3. Pregnant females;
4. Subjects with absolute contraindications of TEE (congenital or acquired upper digestive tract diseases, such as active upper gastrointestinal hemorrhage, esophageal obstruction or stenosis, esophageal tumor, esophageal lacerations and perforations, esophageal diverticula) or relative contraindications (changes in consciousness or lack of cooperation, history of cervical and mediastinal radiotherapy, history of recent esophageal surgery, esophageal varicosity, clotting disorders, cervical disease and injury, active esophagitis, active gastrointestinal ulcers, hiatal hernia, poor cardiopulmonary function, airway damage, pharyngeal space-occupying lesions, etc.), who are expected to be at high risks;
5. Any other subjects who should not participate in this study in the investigator's opinion.