Clinical Performance Evaluation of the Vivid Pioneer Diagnostic Ultrasound System

Launched by JUAN ZHANG · Jul 4, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new ultrasound machine called the Vivid Pioneer, which is used to take detailed pictures of the heart. The study is for people who need a special type of heart ultrasound called transesophageal echocardiography (TEE). This test involves putting a small probe down the throat to get clear images of the heart while a person is under anesthesia during surgery. The goal is to see how well the new device works compared to the machines currently used in hospitals, looking at things like the quality of the images, how easy it is to use, and whether it is safe and reliable.

Adults aged 18 and older who need this type of heart ultrasound during surgery may be eligible to join the study, as long as they can understand and agree to participate. People who are pregnant, have certain throat or digestive tract problems, or are in emergency medical situations will not be able to take part. If you join, the doctors will first use the new device to take pictures of your heart through the chest, then use the probe down your throat while you’re under anesthesia. After that, they will switch to the regular ultrasound machine to continue the surgery safely. The doctors will also give feedback about their experience using the new device to help improve it. This study is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• 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.