UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory research on improving the accuracy of intraoperative landmark teaching systems using artificial intelligence
Acronym	Exploratory research on improving the accuracy of intraoperative landmark teaching systems using artificial intelligence
Scientific Title	Exploratory research on improving the accuracy of intraoperative landmark teaching systems using artificial intelligence
Scientific Title:Acronym	Exploratory research on improving the accuracy of intraoperative landmark teaching systems using artificial intelligence
Region	Japan

Condition
Condition	Benign gallbladder disease
Classification by specialty	Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop artificial intelligence (AI) based intraoperative landmark teaching system for laparoscopic cholecystectomy and confirm the function of the AI device.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy of landmark detection
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	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Benign gallbladder disease for which laparoscopic cholecystectomy is indicated
Key exclusion criteria	1) Patients with severe cardiac dysfunction who were diagnosed by anesthesiology and cardiology and were judged to be unable to undergo general anesthesia. 2) Patients with severe respiratory distress who were judged to be unable to undergo general anesthesia based on the diagnosis of anesthesiology and respiratory medicine. 3) Patients with severe liver damage or severe cirrhosis 4) Patients who participated in other clinical trials within 4 months 5) Other patients who the doctor in charge of this study deems inappropriate
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
Email	oitagps@oita-u.ac.jp

Public contact
Name of contact person	1st name Atsuro Middle name Last name Fujinaga
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
Email	a-yoshimura@oita-u.ac.jp

Sponsor
Institute	Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine
Institute
Department

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
Email	a-yoshimura@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

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 12 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	2020 Year 09 Month 23 Day
Date of IRB
Anticipated trial start date	2021 Year 10 Month 13 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2021 Year 10 Month 12 Day
Last modified on	2021 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052206