Multimodal Ultrasound Data CollectionNCT07900529
A Clinical Multimodal Data Collection Study for the Development of Autonomous Ultrasound Scanning Robotic Technology
An observational study of Multimodal Ultrasound Data Collection, run by First People's Hospital of Hangzhou.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multimodal Ultrasound Data Collection
- How many people
- 30,000 participants
- Where
- No sites listed yet
- Study dates
- 28 Oct 2026to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adults aged 18 to 80 years.
- Individuals scheduled to undergo routine clinically indicated ultrasound examinations of the hepatobiliary system, pancreas, spleen, thyroid, carotid arteries, kidneys, urinary bladder, and/or prostate.
- Individuals with the legal capacity to provide informed consent, who can understand the study procedures and voluntarily provide written informed consent.
- Individuals able to cooperate with necessary breathing and body positioning instructions during routine ultrasound examinations.
- For prostate ultrasound examinations, only male participants will be included.
Who cannot join
- Patients with critical or emergency conditions or unstable vital signs for whom research-related data recording may delay necessary clinical diagnosis or treatment.
- Individuals who cannot adequately understand the study information or provide valid informed consent.
- Individuals who are unable or unwilling to comply with the body positioning or breathing instructions required for routine ultrasound examinations.
- Individuals who do not consent to in-hospital audio acquisition or the processing of research data as described in the informed consent form.
- Individuals considered unsuitable for study participation by the investigator based on participant safety or the priority of routine clinical care.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Multimodal Ultrasound Data Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Routine Ultrasound Multimodal Data Collection Group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first participant enrollment through completion of data collection, up to 8months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start28 Oct 2026 (estimated)
- Primary completion28 Oct 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multimodal Ultrasound Data CollectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900529
- Sponsor's protocol ID
- 2026IIT124-1
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Multimodal Data Collection Study for the Development of Autonomous Ultrasound Scanning Robotic Technology
- ClinicalTrials.gov ID
- NCT07900529
- Acronym / sponsor ID
- 2026IIT124-1
- Conditions
- Multimodal Ultrasound Data Collection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine Ultrasound Multimodal Data Collection Group | – | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Adults aged 18 to 80 years.
- Individuals scheduled to undergo routine clinically indicated ultrasound examinations of the hepatobiliary system, pancreas, spleen, thyroid, carotid arteries, kidneys, urinary bladder, and/or prostate.
- Individuals with the legal capacity to provide informed consent, who can understand the study procedures and voluntarily provide written informed consent.
- Individuals able to cooperate with necessary breathing and body positioning instructions during routine ultrasound examinations.
- For prostate ultrasound examinations, only male participants will be included.
Key exclusion criteria (5 listed)
- Patients with critical or emergency conditions or unstable vital signs for whom research-related data recording may delay necessary clinical diagnosis or treatment.
- Individuals who cannot adequately understand the study information or provide valid informed consent.
- Individuals who are unable or unwilling to comply with the body positioning or breathing instructions required for routine ultrasound examinations.
- Individuals who do not consent to in-hospital audio acquisition or the processing of research data as described in the informed consent form.
- Individuals considered unsuitable for study participation by the investigator based on participant safety or the priority of routine clinical care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative Number of Valid Multimodal Ultrasound Data Units
Time frame: From first participant enrollment through completion of data collection, up to 8months.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Multimodal Ultrasound Data Collection, run by First People's Hospital of Hangzhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yana Xu, Ph.D (+86 15395823818, 980954564@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Number of Valid Multimodal Ultrasound Data Units (time frame: From first participant enrollment through completion of data collection, up to 8months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.