AI (Artificial Intelligence)AINCT07171502
AI-Assisted Ultrasound-Guided Nerve Block: Model Development and Performance Assessment
A study testing AI Annotation and manual annotation in people with AI (Artificial Intelligence) and Ultrasound-Guided Nerve Blocks, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
Trial summary
This study intends to have experts with over 10 years of experience in ultrasound-guided regional anesthesia acquire 1,000 target images. These images will be annotated by both an AI model and human experts, and the model's annotations will be evaluated by a panel of 10 specialists. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- AI (Artificial Intelligence), Ultrasound-Guided Nerve Blocks
- What is being tested?
- AI Annotation and manual annotation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years
- BMI between 19-23 kg·m-²
- ASA physical status classification I-II
- Normal orientation and able to cooperate with physical examination.
Who cannot join
- Patient refusal
- Infection, trauma, skin defect, deformity, or other abnormalities at the intended nerve block site
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Sixth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
This study intends to have experts with over 10 years of experience in ultrasound-guided regional anesthesia acquire 1,000 target images. These images will be annotated by both an AI model and human experts, and the model's annotations will be evaluated by a panel of 10 specialists. The primary outcome is the accuracy of identifying the target anatomical structures in the annotated images. Secondary outcomes include the number of true positive, false positive, true negative, and false negative structures, the time required for annotation, and the potential application of the AI model in assisting the performance of ultrasound-guided regional blocks.
- Being tested
- AI Annotation, manual annotation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI AnnotationDevice
Use the AI model to assist in annotating the target images.
manual annotationOther
Use the manual to annotate the target images.
| Study group | Role | What they receive |
|---|---|---|
| AI Annotation | Experimental | Not described Receives: Device: AI Annotation |
| Manual Annotation | Placebo comparator | Not described Receives: Other: manual annotation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of identifying the target anatomical structures in the annotated images.
Measured: From enrollment to the end of treatment at 4 months
Secondary outcomes (6)
The number of true positive (TP) structures
Measured: From enrollment to the end of treatment at 4 months
The number of false positive (FP) structures
Measured: From enrollment to the end of treatment at 4 months
The number of true negative (TN) structures
Measured: From enrollment to the end of treatment at 4 months
The number of false negative (FN) structures
Measured: From enrollment to the end of treatment at 4 months
The annotation time (time from the start to the end of annotation)
Measured: From enrollment to the end of treatment at 4 months
An evaluation of the AI model if applied to assist in performing ultrasound-guided regional blocks: a) its impact on block failure rate (increase, no effect, decrease); b) its impact on the incidence of adverse events (increase, no effect, decrease)
Measured: From enrollment to the end of treatment at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start30 Sep 2025
- Primary completion30 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AI (Artificial Intelligence)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Xu, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171502
- Sponsor's protocol ID
- AI-Sacral Plexus
- Acronym
- AI
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Assisted Ultrasound-Guided Nerve Block: Model Development and Performance Assessment
- ClinicalTrials.gov ID
- NCT07171502
- Acronym / sponsor ID
- AI / AI-Sacral Plexus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Sep 2025 (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 intends to have experts with over 10 years of experience in ultrasound-guided regional anesthesia acquire 1,000 target images. These images will be annotated by both an AI model and human experts, and the model's annotations will be evaluated by a panel of 10 specialists. The primary outcome is the accuracy of identifying the target anatomical structures in the annotated images. Secondary outcomes include the number of true positive, false positive, true negative, and false negative structures, the time required for annotation, and the potential application of the AI model in assisting the performance of ultrasound-guided regional blocks.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI Annotation | Experimental | Device: AI Annotation |
| Manual Annotation | Placebo comparator | Other: manual annotation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-70 years
- BMI between 19-23 kg·m-²
- ASA physical status classification I-II
- Normal orientation and able to cooperate with physical examination.
Key exclusion criteria (3 listed)
- Patient refusal
- Infection, trauma, skin defect, deformity, or other abnormalities at the intended nerve block site
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI AnnotationUse the AI model to assist in annotating the target images. | Device | AI Annotation |
| manual annotationUse the manual to annotate the target images. | Other | Manual Annotation |
Primary outcome
The accuracy of identifying the target anatomical structures in the annotated images.
Time frame: From enrollment to the end of treatment at 4 months
6 secondary outcomes
The number of true positive (TP) structures
Time frame: From enrollment to the end of treatment at 4 months
The number of false positive (FP) structures
Time frame: From enrollment to the end of treatment at 4 months
The number of true negative (TN) structures
Time frame: From enrollment to the end of treatment at 4 months
The number of false negative (FN) structures
Time frame: From enrollment to the end of treatment at 4 months
The annotation time (time from the start to the end of annotation)
Time frame: From enrollment to the end of treatment at 4 months
An evaluation of the AI model if applied to assist in performing ultrasound-guided regional blocks: a) its impact on block failure rate (increase, no effect, decrease); b) its impact on the incidence of adverse events (increase, no effect, decrease)
Time frame: From enrollment to the end of treatment at 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI Annotation and manual annotation in people with AI (Artificial Intelligence) and Ultrasound-Guided Nerve Blocks, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of identifying the target anatomical structures in the annotated images. (time frame: From enrollment to the end of treatment at 4 months). 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 6 Jan 2026.