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NCT Number: NCT07066449

Clinical Performance Evaluation of a Diagnostic Ultrasound System

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital, Nanjing Medical University

Nanjing, China

Location status: Recruiting

Location contact

Juan Zhang

CONTACT

[email protected]

+86 18951670387

Juan Zhang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subjects who have been previously enrolled in this study or are participating in other clinical trials;
  • Subjects with any medical emergency condition requiring urgent treatment;
  • Pregnant females;
  • 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;
  • Any other subjects who should not participate in this study in the investigator's opinion.

Treatment and study plan

Primary outcomes

  1. The main evaluation indicators include Overall system operation, Reliability, System operability, Overall image quality, etc., and the evaluation results are represented by five grades: Excellent, Very good, Good, Bad, and Very bad.

    Time frame: From enrollment to Day 1 (Visit 1)

Other outcomes

  1. The other evaluation indicators include Imaging Mode , Structural Heart Disease Workflow Productivity Tools, FlexiSlice Improvements , The results are expressed as a score (5 to 1 point), with higher scores indicating better performance

    Time frame: From enrollment to Day1(Visit1)

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Zhang

CONTACT

[email protected]

+86 18951670387

Zhihui Z Zhang, Zhi

CONTACT

[email protected]

+86 18531524215

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

Clinical Performance Evaluation of the Vivid Pioneer Diagnostic Ultrasound System

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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