UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000035213
Receipt No. R000039889
Scientific Title Real-time Artificial Intelligence Aided Diagnosis of Colorectal Polyps during Colonoscopy -a Multicenter Clinical Trial with the EndoBRAIN Technology-
Date of disclosure of the study information 2019/04/08
Last modified on 2022/01/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.