UMIN-CTR Clinical Trial

Basic information
Public title	Toward laparoscopic cholecystectomy using an intraoperative artificial intelligence landmark guidance system: Exploratory study
Acronym	J-SUMMIT-C-01
Scientific Title	Japanese Surgical Utilizing Medical Machine with Artificial Intelligence Trials
Scientific Title:Acronym	J-SUMMIT-C-01
Region	Japan

Condition
Condition	benign gallbladder disease
Classification by specialty	Hepato-biliary-pancreatic surgery
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	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Accuracy of landmark detection
Key secondary outcomes	Operative time Amount of blood loss Conversion ratio to conventional surgery Morbidity Mortality

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	Have a gallbladder disease indicated for LC
Key exclusion criteria	1) Patients with severe cardiac dysfunction who are deemed unable to undergo general anesthesia based on an anesthesiologic or cardiovascular diagnosis. Patients with severe respiratory disorders who are deemed unable to undergo general anesthesia based on an anesthesiologic or respiratory diagnosis. 3) Patients with severe liver dysfunction or severe cirrhosis 4) Patients who participated in another clinical trial in the last 4 months 5) Patients who are otherwise deemed ineligible for the study by the doctor in charge
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 Hiroaki Middle name Last name Nakanuma
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
Email	h-nakanuma@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	h-nakanuma@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	2021 Year 10 Month 22 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	No longer recruiting
Date of protocol fixation	2019 Year 06 Month 07 Day
Date of IRB	2019 Year 06 Month 07 Day
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 10 Month 22 Day
Last modified on	2021 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052329