UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035213 |
|---|---|
| Receipt number | 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 07:17:28 |
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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)
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
ibusiginjp@gmail.com
Sponsor or person
Institute
Oslo University; Showa University; King's college
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039889
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