UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049977 |
|---|---|
| Receipt number | R000056875 |
| Scientific Title | Development of an artificial intelligence system (Version2) using deep learning to indicate anatomical landmarks during laparoscopic gastrectomy |
| Date of disclosure of the study information | 2023/01/16 |
| Last modified on | 2024/07/08 10:41:29 |
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Basic information
Public title
Development of an artificial intelligence system (Version2) using deep learning to indicate anatomical landmarks during laparoscopic gastrectomy
Acronym
Development of an artificial intelligence system (Version2) using deep learning to indicate anatomical landmarks during laparoscopic gastrectomy
Scientific Title
Development of an artificial intelligence system (Version2) using deep learning to indicate anatomical landmarks during laparoscopic gastrectomy
Scientific Title:Acronym
Development of an artificial intelligence system (Version2) using deep learning to indicate anatomical landmarks during laparoscopic gastrectomy
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To revise the artificial intelligence (AI) based intraoperative landmark indicating system for laparoscopic gastrectomy and confirm the improved accuracy of the AI device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improved accuracy of laparoscopic gastrectomy with intraoperative indicating system assisted by artificial intelligence
Key secondary outcomes
Evaluation of landmark indicating ability by the external review committee
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven gastric carcinoma (pap, tub1, tub2, por1, por2, sig, or muc).
2) Clinical Stage I to III gastric carcinoma according to the Japanese classification system.
3) Regardless of occupation and number of tumors.
4) PS (ECOG) 0 or 1.
5) Sufficient organ function.
6) Provided written informed consent.
Key exclusion criteria
1)BMI over 30
2)History of gastrectomy
3)Severe mental disease.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Inomata |
Organization
Oita University Faculty of Medicine
Division name
Gastroenterological and Pediatric Surgery
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama-machi, Yufu city, Oita
TEL
097-586-5843
oitagps@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Aoyama |
Organization
Oita University Faculty of Medicine
Division name
Gastroenterological and Pediatric Surgery
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama-machi, Yufu city, Oita
TEL
097-586-5843
Homepage URL
http://www.surgery1.med.oita-u.ac.jp
y-aoyama@oita-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine
Address
1-1 Idaigaoka, Hasama-machi, Yufu city, Oita
Tel
097-586-5843
y-aoyama@oita-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
大分大学医学部 消化器・小児外科
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 16 | 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
10
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
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an exploratory study, not a controlled trial. Therefore, strict randomization is not necessary and no allocation center will be set up.
Management information
Registered date
| 2023 | Year | 01 | Month | 06 | Day |
Last modified on
| 2024 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056875
