Clinical Performance Evaluation of a Diagnostic Ultrasound System

NCT07066449 | Recruiting

• 1 other identifier: KY20250225-05
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Echocardiography

Outcome Measures

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.

  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

  From enrollment to Day1（Visit1）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are required to undergo intraoperative transesophageal echocardiography according to the current clinical practice standards;

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, China

RECRUITING

Central Study Contacts

Juan Zhang

CONTACT

+86 18951670387; yinyinye9157793@126.com

Zhihui Z Zhang, Zhi

CONTACT

+86 18531524215; zhihui.zhang2@gehealthcare.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: July 15, 2025
• Study Start: August 12, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

CN (1)