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

Launched by TONGJI HOSPITAL · Jun 27, 2024

Keywords

ClinConnect Summary

This study is testing a remote, automatic ultrasound system (CORUS-A30) to see if it can safely and effectively perform ultrasound scans of multiple organs—like the liver, gallbladder, pancreas, spleen, kidneys, thyroid, and carotid arteries—without a clinician holding the probe. It’s an observational study, meaning researchers watch how the robot works in real-world use and check the images with a panel of three experts to decide if the results meet diagnostic standards. The main question is whether the robot can complete these scans reliably and whether there are any safety concerns during the scanning process.

Who can join? Adults 18 years and older who need an ultrasound exam and can give informed consent. The study also accepts healthy volunteers. Key criteria include being 18+, needing an ultrasound, and agreeing to participate. Exclusions include allergy to ultrasound gel, inability to tolerate long ultrasound sessions, recent severe trauma or burns, pregnancy or breastfeeding, participation in another trial in the last month, or other reasons the researchers deem unsuitable. Participants will undergo ultrasound sessions using the remote system, with images reviewed to assess quality and safety. The trial is currently enrolling by invitation at Tongji Hospital in Wuhan, China, with about 1,000 participants planned.

Gender

ALL

Eligibility criteria

• 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.