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

Clinical Application of Multi-organ Multi-task Autonomous Ultrasound Embodied Intelligent Robot

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 Overview

• Status: Enrolling by invitation
• Conditions: Thyroid; Ultrasound; Liver; Kidney; Pancreas; Gallbladder; Carotid Artery; Spleen
• Intervention / Treatment: Device: Test equipment: Name: Remote automatic ultrasound diagnostic system (Wuhan Cooper Technology Co., Ltd.) Model: CORUS-A30

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Xin-Wu Cui

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study will recruit adults over 18 years old, especially those who need multi-organ ultrasound examinations. Participants need to be able to understand and sign the informed consent. We hope to include patients of different ages, genders, and health conditions to ensure the wide applicability of the study results. Your participation will help us test and improve the autonomous ultrasound robot so that it can work effectively in a variety of populations.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Age ≥ 18 years old, regardless of gender, who need ultrasound examination; 3) Voluntarily participat	Device: Test equipment: Name: Remote automatic ultrasound diagnostic system (Wuhan Cooper Technology Co., Ltd.) Model: CORUS-A30; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2024
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Multitasking; Clinical application; Ultrasound Intelligent Robot; Automated Ultrasound
• Other Study ID Numbers: 2024S730

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No