Clinical Research Directory

A Clinical Multimodal Data Collection Study for the Development of Autonomous Ultrasound Scanning Robotic Technology

Sponsor: First People's Hospital of Hangzhou

Summary

This study is a prospective, multicenter, observational clinical study designed to collect multimodal ultrasound data to support the research and development of intelligent ultrasound imaging and autonomous ultrasound scanning robotic technologies. The study will be conducted at three hospitals in China: Hangzhou First People's Hospital, Hangzhou Cancer Hospital, and Tonglu County First People's Hospital. Adults aged 18 to 80 years who are scheduled to undergo routine clinical ultrasound examinations may be invited to participate. The examinations may include the hepatobiliary system, pancreas, spleen, thyroid, carotid arteries, kidneys, urinary bladder, and prostate. Participants will undergo their usual ultrasound examinations without changes to their clinical diagnosis or treatment. A lightweight position and orientation sensor will be attached to the non-patient-contact side of the existing ultrasound probe to record probe movements while ultrasound images and videos are collected. The study will also collect information about standard imaging planes, lesions, measurements, image quality, and routine breathing or positioning instructions given by the examining clinician. Verbal instructions will be processed locally within the hospital's controlled data environment. Only confirmed structured information about predefined instructions and their timestamps will be retained for research purposes. Raw audio recordings will not be transferred outside the hospital. The study aims to collect 100,000 valid ultrasound data units, including 51,000 units in the first phase. A participant may contribute more than one data unit. The collected data will undergo quality control, de-identification or anonymization, and institutional data security review before any approved external use. This study does not involve experimental medications, invasive procedures, or robotic scanning performed on participants. Participation is not expected to provide direct medical benefits. The study may help improve data collection methods and support future development of intelligent ultrasound and autonomous scanning technologies. Research data will be handled in accordance with the approved study protocol, informed consent, and applicable data protection requirements.

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