UMIN-CTR Clinical Trial

Basic information
Public title	Real-time Artificial Intelligence Aided Diagnosis of Colorectal Polyps during Colonoscopy -a Multicenter Clinical Trial with the EndoBRAIN Technology-
Acronym	EndoBRAIN international
Scientific Title	Real-time Artificial Intelligence Aided Diagnosis of Colorectal Polyps during Colonoscopy -a Multicenter Clinical Trial with the EndoBRAIN Technology-
Scientific Title:Acronym	EndoBRAIN international
Region	Japan Europe

Condition
Condition	Diminutive rectosigmoid polyps
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This international multicenter accuracy trial investigates the diagnostic performance of the real-time artificial intelligence system (EndoBRAIN, Cybernet Systems, Corp. Tokyo) for diagnosis of colorectal polyps in real-World colonoscopy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare the sensitivity of identifying diminutive colorectal polyps as adenomas during colonoscopy with the combination of visual inspection and the use of the EndoBRAIN technology to visual inspection alone.
Key secondary outcomes	1. To compare the specificity of identifying diminutive colorectal polyps as adenomas during colonoscopy with the combination of visual inspection and the use of the EndoBRAIN CAD technology to visual inspection alone. 2. To estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the combination of visual inspection and the use of the EndoBRAIN CAD technology 3. To assess whether the diagnostic performance of the combination of visual inspection and the use of the EndoBRAIN CAD technology of endoscopists meets the PIVI-1 and PIVI-2 guideline recommendations for diagnostic performance of the American Society of Gastrointestinal Endoscopy (ASGE)12: >90% accuracy in predicting post-polypectomy surveillance intervals based on optical biopsy with high confidence (PIVI-1*); >90% NPV in identifying rectosigmoid diminutive adenomas based on optical biopsy with high confidence (PIVI-2)6. 4. To estimate the percentage of diminutive colorectal polyps from which endocytoscopic images can be successfully captured (acquisition rate). 5. To estimate the rate of high-confidence diagnosis with EndoBRAIN as compared to visual polyp inspection alone. 6. To evaluate the colonoscopy performance with an endocytoscope including the EndoBRAIN device with regard to cecal intubation rate, insertion time, and complications.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Diagnosis using EndoBRAIN. (The present study does not require additional invasive interventions as compared to clinical practice. )
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Individuals 18 years or older who are scheduled for screening, surveillance, diagnostic, or therapeutic colonoscopy at the trial centres with diminutive rectosigmoid polyps (<=5mm).
Key exclusion criteria	1. Diminutive polyps with known histology 2. Inflammatory bowel disease 3. Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis) 4. History of chemotherapy or radiation therapy for colorectal lesions 5. Inability to undergo polypectomy (e.g. intake of anticoagulants, comorbidities, or patient refusal) 6. Pregnancy
Target sample size	345

Research contact person
Name of lead principal investigator	1st name Oyvind Holme; Michael Bretthauer;Yuichi Mori (PIs) Middle name Last name Amyn Haji; Shin-ei Kudo (co-PIs)
Organization	Oslo University Hospital/University of Oslo, Oslo (OH; MB) Showa University Northern Yokohama Hospital/Showa University, Tokyo (YM; SK) King's college hospital, London (AH)
Division name	Clinical Effectiveness Research Group(OH; MB); Digestive Disease Center (YM, SK); Endoscopy & Colorectal Surgery (AH)
Zip code	x
Address	Sognsvannsveien 21 0372 Oslo (OH; MB); 35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama (YM, SK); Denmark Hill, London (AH); Denmark Hill, London
TEL	+47-22850550(+81-459497000)(+44-2032999000)
Email	oyvind.holme@medisin.uio.no

Public contact
Name of contact person	1st name Yuichi Middle name Last name Mori
Organization	Showa University Northern Yokohama Hospital, Yokohama
Division name	Digestive Disease Center
Zip code	2248503
Address	35-1, Chigasaki-tyuo, Tsuzuki-ku
TEL	+81-45-949-7000
Homepage URL
Email	ibusiginjp@gmail.com

Sponsor
Institute	Oslo University; Showa University; King's college
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Olympus Corp., Tokyo (to Oslo Univ.)

IRB Contact (For public release)
Organization	Showa University Northern Yokohama Hospital; Regonale Komiteer For Medisinsk Og Helsefaglig Forskningsetikk
Address	35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama; Gullhaugveien 1-3, 0484 Oslo
Tel	+81459497000; +4722857547
Email	irb02syh@ofc.showa-u.ac.jp post@helseforskning.etikkom.no

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	Vestre Viken Baerum Hospital Showa Univeristy Northern Yokohama Hospital King's College Hospital

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 08 Day

Related information
URL releasing protocol	NA
Publication of results	Unpublished

Result
URL related to results and publications	NA
Number of participants that the trial has enrolled	1242
Results	To be disclosed after publication.
Results date posted	2022 Year 01 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	To be disclosed after publication.
Participant flow	To be disclosed after publication.
Adverse events	To be disclosed after publication.
Outcome measures	To be disclosed after publication.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 12 Month 03 Day
Date of IRB	2018 Year 12 Month 03 Day
Anticipated trial start date	2019 Year 04 Month 08 Day
Last follow-up date	2021 Year 05 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The target sample size (N=345) is the number of diminutive rectosigmoid adenomas detected during the study(not the number of the recruited patients) In this study, patients and endoscopists are not blinded to the intervention (i.e., use of EndoBRAIN), however pathologists are blinded to the optical diagnosis made by the endoscopists.

Management information
Registered date	2018 Year 12 Month 11 Day
Last modified on	2022 Year 01 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039889