Clinical Performance Evaluation of a Diagnostic Ultrasound System
ConditionEchocardiography
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGE Healthcare
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Subjects who are required to undergo intraoperative transesophageal echocardiography according to the current clinical practice standards;
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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）Sponsors and contacts
Click on the lead sponsor to view all of their trials.
GE Healthcare
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Sponsor institution
Source ClinicalTrials.gov