Testing a new cardiac ultrasound system
Clinical Performance Evaluation of the Vivid Pioneer Diagnostic Ultrasound System
This project will test a new cardiac ultrasound system in adults having intraoperative transesophageal echocardiography to see if it provides clear images and fits clinical workflow.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GE Healthcare Industry-sponsored |
| Locations | 1 site (Nanjing) |
| Trial ID | NCT07066449 on ClinicalTrials.gov |
What this trial studies
This observational project will enroll adults who are scheduled for intraoperative transesophageal echocardiography (TEE) and who meet inclusion criteria. Investigators will first use the investigational device to perform transthoracic echocardiography (TTE), then perform TEE after anesthesia; the investigational probe and console will be used for imaging and then the site’s standard commercial device will be used for intraoperative guidance to avoid delaying care. Clinicians will rate overall image quality, the user interface, workflow, presets, and system functions. No experimental treatments are given and standard clinical care is maintained throughout.
Who should consider this trial
Good fit: Adults (age 18 or older) who need intraoperative transesophageal echocardiography, can provide informed consent, and meet the study’s inclusion and exclusion criteria are ideal candidates.
Not a fit: Patients with absolute or relative contraindications to TEE, pregnant people, those in medical emergencies, or those unable to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the device could deliver clearer cardiac images and smoother workflow during intraoperative echocardiography, potentially improving procedural guidance.
How similar studies have performed: Comparable performance comparisons of cardiac ultrasound systems have been performed previously and often show incremental improvements in image quality and usability, though results vary by device.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing
- Nanjing First Hospital, Nanjing Medical University — Nanjing, China (Recruiting)
Study contacts
- Study coordinator: Juan Zhang
- Email: yinyinye9157793@126.com
- Phone: +86 18951670387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.