Clinical Trial to Evaluate the Effectiveness and Safety of a Remote Automated Ultrasound Diagnostic System for Automated Ultrasound Examinations: a Prospective, Multicenter Study

N/AEnrolling By InvitationNCT06487312

Tongji Hospital1,000 enrolled

Overview

The purpose of this clinical trial is to verify the safety and effectiveness of the remote automatic ultrasound diagnosis system produced by Wuhan Cooper Technology Co., Ltd. for automatic ultrasound examination. It aims to answer the main questions: Can the robot complete automatic ultrasound scanning of multiple systems and organs such as liver, gallbladder, spleen, pancreas, kidney, thyroid, carotid artery, etc.? Will there be medical safety issues during the robot\'s scanning process?

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Ultrasound Thyroid Carotid Artery Liver Gallbladder Spleen Pancreas Kidney

Test equipment: Name: Remote automatic ultrasound diagnostic system (Wuhan Cooper Technology Co., Ltd.) Model: CORUS-A30DEVICE

A clinical trial to evaluate the effectiveness and safety of a remote automated ultrasound diagnostic system for automated ultrasound examination using a remote automated ultrasound diagnostic system (model: CORUS-A30, Wuhan Cooper Technology Co., Ltd., China).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 1\) Aged ≥ 18 years old, regardless of gender; 2) Those who need to undergo ultrasound examination; 3) Those who voluntarily participate in this trial and sign the informed consent form. Exclusion Criteria: * 1\) Those who are allergic to ultrasound coupling agents; 2) Those who are unable to undergo long-term ultrasound examinations due to physical or mental reasons (such as intellectual disability, mental illness, etc.); 3) Those who have suffered severe trauma or burns within the past month; 4) Pregnant or breastfeeding women; 5) Those who have participated in other clinical trials within the past month; 6) Other subjects deemed by the researchers to be unsuitable for participating in the trial.

Outcomes

Primary Outcomes

Image scanning pass rate

Each subject is subjected to ultrasound examination using the corresponding probe using the test device. The image quality of each part is evaluated according to the examination site and the image evaluation standards of each part (see Appendix 1); whether it meets the doctor's diagnostic needs is determined according to the scan completeness evaluation standards (see Appendix 2). The examination sites include: abdomen (liver, gallbladder, pancreas, spleen and kidney), superficial small organs (thyroid) and peripheral blood vessels (carotid artery). Each subject can undergo examination of all parts or some parts on the same day. If the subject has a history of organ resection surgery, ultrasound examination of the corresponding part will not be performed. The expert group consists of three researchers. The three expert group researchers evaluate the ultrasound image video and standard cross-section diagram collected by the test device back to back. When the results are inconsistent, t

Time frame: 12 months