UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061842 |
|---|---|
| Receipt number | R000070767 |
| Scientific Title | Simulation-based evaluation of medical assistance using a physical AI-equipped robotic arm |
| Date of disclosure of the study information | 2026/06/10 |
| Last modified on | 2026/06/09 11:41:59 |
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Basic information
Public title
Simulation-based evaluation of medical assistance using a physical AI-equipped robotic arm
Acronym
Robotic Arm Medical Assistance Study
Scientific Title
Simulation-based evaluation of medical assistance using a physical AI-equipped robotic arm
Scientific Title:Acronym
Robotic Arm Medical Assistance Study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Applying a robotic arm equipped with physical AI (a technology that integrates AI-based recognition and judgment with physical movement), this study evaluates the feasibility, accuracy, and safety of the following three points in a simulated environment: (1) instrument handover during central venous puncture, (2) autonomous puncture assistance for spinal anesthesia using a lumbar puncture simulator, and (3) autonomous puncture assistance for procedures such as peripheral nerve block, epidural anesthesia, and central venous puncture based on ultrasound image recognition. Through this, the study examines the contribution to reducing the workload of medical staff and decreasing human error.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Verification 1: accuracy of instrument handover (whether the correct item was delivered in the correct order and orientation). Verification 2: puncture success rate. Verification 3: puncture success rate.
Key secondary outcomes
Verification 1: number of errors (misdelivery, dropping, etc.), task duration. Verification 2: puncture site accuracy, task duration, safety assessment by physicians. Verification 3: puncture site accuracy, task duration, safety assessment by physicians.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 24 | years-old | < |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Physicians affiliated with Yamagata University Hospital between May 1, 2026 and March 31, 2030 who provided consent to participate.
Key exclusion criteria
Those who did not provide consent to participate.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Toyama |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
990-9585
Address
2-2-2 Iida-nishi, Yamagata City, Yamagata
TEL
023-628-5400
hayasakatatsuya1101@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Hayasaka |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
990-9585
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata
TEL
023-628-5400
Homepage URL
hayasakatatsuya1101@gmail.com
Sponsor or person
Institute
Yamagata University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Takahashi Industry-Economy Research Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2 Iida-nishi, Yamagata City, Yamagata
Tel
023-628-5015
ikekenkyu@jm.kj.yamagata-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In Japan, especially in rural areas, a serious shortage of medical staff persists, making it difficult to secure personnel for peripheral tasks such as instrument handover and drug preparation during surgery, as well as for high-difficulty puncture procedures such as epidural anesthesia and central venous puncture. This study applies a robotic arm equipped with physical AI, a technology integrating AI-based recognition and judgment with physical movement that is already in practical use in industry, to medicine, and conducts three verifications in a simulated environment. In Verification 1, the robotic arm hands over items (syringe, guidewire, catheter, etc.) to the physician in a simulated central venous puncture setting, and the accuracy of handover, number of errors, and task duration are evaluated. In Verification 2, using a commercial lumbar puncture simulator, the robotic arm performs autonomous puncture based on AI image recognition and motion planning (the physician makes the final decision for each puncture); the puncture success rate, puncture site accuracy, task duration, and safety assessment by physicians are measured. In Verification 3, using a commercial simulator, the robotic arm automatically recognizes nerves and targets from ultrasound images and performs autonomous puncture assistance for peripheral nerve block, epidural anesthesia, central venous puncture, and similar procedures (the physician makes the final decision); the puncture site is not restricted, and the success rate, puncture site accuracy, task duration, and safety assessment by physicians are measured. Participants are physicians affiliated with Yamagata University Hospital who have consented to participate; no patients are directly involved. Statistical analysis uses the chi-square test, Fisher's exact test, Mann-Whitney U test, and t-test, with a significance level of P<0.05.
Management information
Registered date
| 2026 | Year | 06 | Month | 09 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070767
