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

NCT06487312 | Enrolling By Invitation DMC

• 1 other identifier: 2024S730
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Ultrasound; Thyroid; Carotid Artery; Liver; Gallbladder; Spleen; Pancreas; Kidney

Keywords

Ultrasound Intelligent Robot; Multitasking; Automated Ultrasound; Clinical application

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Test equipment: Name: Remote automatic ultrasound diagnostic system (Wuhan Cooper Technology Co., Ltd.) Model: CORUS-A30 DEVICE

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).

Age ≥ 18 years old, regardless of gender, who need ultrasound examination; 3) Voluntarily participat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Xin-Wu Cui

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: July 5, 2024

Record last verified: 2024-06

Locations

CN (1)