NCT07066449 Clinical Performance Evaluation of a Diagnostic Ultrasound System
| NCT ID | NCT07066449 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GE Healthcare |
| Condition | Echocardiography |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-08-12 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07066449 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Echocardiography. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07066449 currently recruiting?
Yes, NCT07066449 is actively recruiting participants. Contact the research team at yinyinye9157793@126.com for enrollment information.
Where is the NCT07066449 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07066449 clinical trial?
NCT07066449 is sponsored by GE Healthcare. The trial plans to enroll 60 participants.