UMIN-CTR Clinical Trial

Basic information
Public title	A Study on Improvement of Accuracy of Assistive Artificial Intelligence for Colonoscopy CADe: Study on Improvement of Accuracy of EndoBRAIN-EYE
Acronym	EndoBRAIN challenge study 2
Scientific Title	A Study on Improvement of Accuracy of Assistive Artificial Intelligence for Colonoscopy CADe: Study on Improvement of Accuracy of EndoBRAIN-EYE
Scientific Title:Acronym	EndoBRAIN challenge study 2
Region	Japan

Condition
Condition	Colorectal tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the accuracy of colorectal polyp detection using computer-aided detection (CADe) in colonoscopy, EndoBRAIN-EYE Ver3.0, and to determine how much the accuracy has improved compared to the previous EndoBRAIN-EYE Ver1.2.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Colorectal lesion detection rate and accuracy (positive diagnosis rate, sensitivity, specificity, positive predictive value, negative predictive value)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients 20 years of age or older undergoing total colonoscopy (2) Patients who fully understand this clinical study and are capable of obtaining consent (3) Patients whose lesion information is not clear before the examination and who do not meet any of the exclusion criteria.
Key exclusion criteria	1) Patients with a history of surgery involving colorectal resection other than appendicectomy 2)Patients with complicated inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.) 3)Patients with more than 6 polyps or complicated colorectal polyposis or hereditary non-polyposis colorectal cancer 4)Patients taking antiplatelet or anticoagulant drugs 5)Pregnant, lactating, or possibly pregnant at the time of examination 6)Patients with other more serious concurrent illnesses, etc., for which the physician in charge determines that the patient is not suitable for the procedure.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Sugimura
Organization	Sano hospital
Division name	Gastroenterology Center
Zip code	655-0031
Address	2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Japan
TEL	078-785-1000
Email	n-sugimura@sano-hospital.or.jp

Public contact
Name of contact person	1st name Naoki Middle name Last name Sugimura
Organization	Sano hospital
Division name	Gastroenterology Center
Zip code	655-0031
Address	2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Japan
TEL	078-785-1000
Homepage URL
Email	n-sugimura@sano-hospital.or.jp

Sponsor
Institute	Sano hospital
Institute
Department

Funding Source
Organization	Sano hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Sano hospital
Address	2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Japan
Tel	078-785-1000
Email	n-sugimura@sano-hospital.or.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	2022 Year 12 Month 09 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	2022 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date	2022 Year 12 Month 16 Day
Last follow-up date	2023 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	NA

Management information
Registered date	2022 Year 12 Month 07 Day
Last modified on	2022 Year 12 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056632