UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054081 |
|---|---|
| Receipt number | R000061755 |
| Scientific Title | Surgical Anatomy Education with Artificial intelligence Surgical Vision System vs. Conventional Methods. |
| Date of disclosure of the study information | 2024/04/06 |
| Last modified on | 2024/04/06 21:36:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Validation Study on the Effectiveness of AI Surgical Education
Acronym
AI Surgical Education Study
Scientific Title
Surgical Anatomy Education with Artificial intelligence Surgical Vision System vs. Conventional Methods.
Scientific Title:Acronym
AI Surgical Education Study
Region
| Japan |
Condition
Condition
Educational Effects of AI
Classification by specialty
| Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An artificial intelligence (AI) system that predicts anatomical structures in real time has the potential to improve surgical anatomy education. Therefore, a randomized clinical trial is needed to compare the group educated by the AI Surgical Vision System (AISVS) (AISVS group) with the conventional method (control group).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The agreement between the medical students' test images and the correct images produced by the surgeons were quantitatively evaluated before and after the practice by calculating precision, recall, Intersection over union (IoU), and Dice coefficient.
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
5th year medical student
Key exclusion criteria
Students who have been retained or who have missed or failed to complete this study.
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | HISASHI |
| Middle name | |
| Last name | SHINOHARA |
Organization
Hyogo Medical University
Division name
Department of Gastroenterological Surgery, Division of Upper G.I. Surgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6111
ei-nakao@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Eiichiro |
| Middle name | |
| Last name | Nakao |
Organization
Hyogo Medical University
Division name
Department of Gastroenterological Surgery, Division of Upper G.I. Surgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6726
Homepage URL
ei-nakao@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University, Ethics Review Board
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
Tel
0798-45-6111
ei-nakao@hyo-med.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
| 2024 | Year | 04 | Month | 06 | 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
82
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyzed images annotated on surgical images on a PC by 5th-year medical students who participated in surgical observation training at Hyogo Medical University between April 1, 2023 and March 1, 2024.
Management information
Registered date
| 2024 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061755
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
