UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062278 |
|---|---|
| Receipt number | R000069777 |
| Scientific Title | Development of an AI System for Real-Time Intraoperative Visualization of Microanatomy |
| Date of disclosure of the study information | 2026/07/21 |
| Last modified on | 2026/07/20 01:44:12 |
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Basic information
Public title
Development of an AI System for Real-Time Intraoperative Visualization of Microanatomy
Acronym
Development of an AI System for Real-Time Intraoperative Visualization of Microanatomy
Scientific Title
Development of an AI System for Real-Time Intraoperative Visualization of Microanatomy
Scientific Title:Acronym
Development of an AI System for Real-Time Intraoperative Visualization of Microanatomy
Region
| Japan |
Condition
Condition
Patients who underwent laparoscopic colorectal surgery or robot-assisted colorectal surgery
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop an AI assisted surgical support system that automatically recognizes microanatomy and surgical devices during operations. Using image data from laparoscopic and robot assisted surgeries, the system will be trained to identify microanatomical structures such as connective tissue, nerves, vessels, and blood based on the expertise and knowledge of experienced surgeons.
Basic objectives2
Others
Basic objectives -Others
By training AI to recognize microanatomy, the system will be able to display the boundaries and extents of these structures directly on the surgical video. This enables surgeons to confirm anatomical structures and their margins in real time, thereby enhancing situational awareness and facilitating safer and smoother surgical procedures. In addition, the system is expected to promote understanding of microanatomy among trainees, medical students, and other healthcare professionals, contributing to more effective surgical education.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AI recognition accuracy for microanatomy in the surgical field (including connective tissue, vessels, nerves, pancreas, vas deferens, ureter, etc.) and for surgical devices. The target structures will be revised or expanded as the study progresses.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent laparoscopic or robot-assisted colorectal surgery at the Department of Gastroenterological, General, Breast and Endocrine Surgery, Sapporo Medical University Hospital; the Department of Gastrointestinal Surgery, Osaka Police Hospital, Osaka International Medical & Science Center; and the Department of Gastrointestinal Surgery, Osaka International Cancer Institute.
Key exclusion criteria
1:Patients who declined participation in this study through the publicly available opt-out document.
2:Cases in which the attending physician judged the patient to be unsuitable for participation in the study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takemasa |
Organization
Osaka International Medical and Science Center, Osaka Keisatsu Hospital
Division name
Department of Surgery
Zip code
543-8922
Address
Karasugatsuji 2-6-40, Tennouji-ku, Osaka City, Osaka
TEL
06-6771-6051
itakemasa@oim.or.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Miyo |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
South 1, West 16, Chuo-ku, Sapporo
TEL
0116112111
Homepage URL
mmiyo@sapmed.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka International Medical and Science Center, Osaka Keisatsu Hospital
Address
Karasugatsuji 2-6-40, Tennouji-ku, Osaka City, Osaka
Tel
06-6771-6051
tiken-info@oim.or.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 | 07 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 07 | Month | 20 | Day |
Last modified on
| 2026 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069777
