UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055621 |
|---|---|
| Receipt number | R000063538 |
| Scientific Title | Construction of an AI-based automated skill assessment system for endoscopic surgery |
| Date of disclosure of the study information | 2024/09/25 |
| Last modified on | 2024/09/25 19:54:32 |
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Basic information
Public title
Construction of an AI-based automated skill assessment system for endoscopic surgery
Acronym
Construction of an AI-based automated skill assessment system for endoscopic surgery
Scientific Title
Construction of an AI-based automated skill assessment system for endoscopic surgery
Scientific Title:Acronym
Construction of an AI-based automated skill assessment system for endoscopic surgery
Region
| Japan |
Condition
Condition
Colorectal cancer, Gastric cancer, Prostatic disease, Gallbladder disease, Gynecological disease
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Obstetrics and Gynecology |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to construct an objective indicator for assessing the skills of endoscopic surgery. We aim to construct an objective assessment indicator by applying artificial intelligence to surgical videos of laparoscopic surgery from multiple facilities.
Basic objectives2
Others
Basic objectives -Others
observational
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
This study aims to construct an AI-based automated skill assessment system for endoscopic surgery. Therefore, no final endpoint is set.
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
The following three points must be met.
1. The surgery involves a colon/rectal resection, gastrectomy, cholecystectomy, or total hysterectomy.
2. The patient has given written consent for the use of the surgical video and patient information.
3. The patient, the applying institution, and the applicant have given written consent for the secondary use of the video.
Key exclusion criteria
The exclusion criteria are as follows.
1. If the patient themselves requests that the use of the data be refused.
2. If the principal investigator deems it inappropriate.
3. Minors
Target sample size
12224
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Ito |
Organization
National Cancer Center East
Division name
Department of Colorectal Surgery, Surgical Device Innovation Office
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
+81-4-7130-0199
maito@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Nobuyoshi |
| Middle name | |
| Last name | Takeshita |
Organization
National Cancer Center Hospital East
Division name
Surgical Device Innovation Office
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
+81-4-7130-0199
Homepage URL
ntakeshi@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center East
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
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel
+81-3-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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 | 09 | Month | 25 | 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
| 2021 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter, non-interventional, non-invasive observational study. This study is a collaborative research project between the National Cancer Center Hospital East, Nagoya City University, Oita University, Chiba University, the University of Tokyo, Hokkaido University, and Toranomon Hospital (Toranomon Hospital will participate until March 31, 2023), and a joint research agreement has been concluded. , and the National Cancer Center Hospital East, which is an institution that only provides surgical videos, examination results and examination application documents submitted to the technical certification examination of each academic society, and existing information other than that of the Japanese Society of Endoscopic Surgery or the Japanese Society of Gynecologic Endoscopy, will use surgical videos and case information provided by the collaborative research facilities to construct an AI automated technical evaluation system. The National Cancer Center Hospital East will oversee the research and expand the data, consider evaluation items for automated technology evaluation, and the National Cancer Center Hospital East and Chiba University will build the AI automated technology evaluation system. Nagoya City University, the University of Tokyo, Chiba University , Toranomon Hospital, and Oita University (Toranomon Hospital until March 31, 2023) will build partnerships with academic societies and collect data from them, and Hokkaido University will examine evaluation items for automated technology evaluation. By fulfilling their respective roles, each facility will build the final deliverable, the AI automated technology evaluation system.
Management information
Registered date
| 2024 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063538
