Testing a new cardiac ultrasound system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nanjing First Hospital, Nanjing Medical University
  Nanjing, China Recruiting

Study contacts

• Study coordinator: Juan Zhang
• Email: yinyinye9157793@126.com
• Phone: +86 18951670387

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.