An observational study in Multimodal Ultrasound Data Collection, sponsored by First People's Hospital of Hangzhou. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by First People's Hospital of Hangzhou · Observational
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.
First People's Hospital of Hangzhou is the lead sponsor of 73 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adults aged 18 to 80 years undergoing clinically indicated routine ultrasound examinations at three participating hospitals in China: Hangzhou First People's Hospital, Hangzhou Cancer Hospital, and Tonglu County First People's Hospital. Eligible participants will be prospectively recruited from patients scheduled for ultrasound examinations of the hepatobiliary system, pancreas, spleen, thyroid, carotid arteries, kidneys, urinary bladder, and/or prostate. Both participants with normal and abnormal ultrasound findings may be included. Prostate examinations will include male participants only. All participants must provide written informed consent before enrollment. No study-specific invasive procedures, experimental treatments, or additional follow-up visits are planned.
**Inclusion Criteria:**
**Exclusion Criteria:**
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group includes adults aged 18-80 years undergoing routine clinical ultrasound examinations at three participating hospitals in China. Eligible participants will be prospectively enrolled after providing written informed consent. During routine ultrasound examinations, ultrasound images/videos and probe position and orientation will be recorded using a lightweight sensor attached to the non-patient-contact side of the ultrasound probe. Standard imaging planes, lesions, measurements, image quality, and structured clinician instructions with timestamps will also be collected. Audio will be processed locally within the hospital, and raw audio will not be transferred outside the hospital. No investigational treatment, invasive procedures, or robotic scanning will be performed. Routine clinical diagnosis and treatment will not be altered. No study-specific follow-up is planned.
Cumulative Number of Valid Multimodal Ultrasound Data Units
The cumulative number of valid multimodal ultrasound data units collected during routine clinical ultrasound examinations across the three participating hospitals. Data include ultrasound images or videos, corresponding probe position and orientation, standard imaging plane and lesion annotations, and structured operation command events where applicable. Data validity will be assessed through quality checks for completeness, temporal synchronization, annotation quality, and de-identification. The study aims to collect 100,000 valid ultrasound data units, including 51,000 units in the first phase and 49,000 units in subsequent data collection. Each participant may contribute one or more valid data units.
Time frame: From first participant enrollment through completion of data collection, up to 8months.
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant-level multimodal ultrasound data may be shared with specifically authorized project researchers and designated third-party organizations in accordance with the approved study protocol, informed consent, institutional data security requirements, and contractual agreements. Shared data may include ultrasound images and videos, probe position and orientation data, and associated structured annotations. Direct personal identifiers and raw audio recordings will not be shared. Data access will be restricted to approved research, algorithm development, and other explicitly authorized project purposes. Public access to individual participant data is not planned. All shared data will be stored and processed within China, and further unauthorized sharing or use beyond the approved scope will be prohibited.
Supporting information: Study protocol
Time frame: De-identified individual participant data and associated data dictionaries will be made available to specifically authorized researchers following institutional data quality control, de-identification, and data security review. Data sharing will begin in Oct, 2026 and continue until May, 2027, in accordance with the approved study protocol, informed consent, and applicable data-sharing agreements. Raw audio recordings and directly identifiable personal information will not be shared. Public data release is not planned.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2026, 0 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
First People's Hospital of Hangzhou