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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000044196
Receipt No. R000050469
Scientific Title Bench-mark test for assessment of EndoBRAIN-EYE in the European setting
Date of disclosure of the study information 2021/05/13
Last modified on 2021/05/13

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Basic information
Public title Bench-mark test for assessment of EndoBRAIN-EYE in the European setting
Acronym Euro-EndoBRAIN-EYE
Scientific Title Bench-mark test for assessment of EndoBRAIN-EYE in the European setting
Scientific Title:Acronym Euro-EndoBRAIN-EYE
Region
Europe

Condition
Condition Premarket retrospective study (Multi-reader, multi-case study [MRMC])
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of the automated polyp detection system (EndoBRAIN-EYE) for colonoscopy under the intended use condition.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Whether EndoBRAIN-EYE increases the sensitivity of polyp detection by less experienced endoscopists
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Physicians who work at European countries where the EU-MDR is valid.
2. Physicians who have performed at least 50 colonoscopies
3. Physicians who provide informed consent regarding their participation in the study
Key exclusion criteria None
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Shin-ei
Middle name
Last name Kudo
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 224-8503
Address 35-1 Chigasakichuo, Tsuzuki Ward, Yokohama, Kanagawa, Japan
TEL +81459497000
Email kudos@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Yuichi
Middle name
Last name Mori
Organization Showa University Northern Yokohama Hospital / University of Oslo
Division name Digestive Disease Center
Zip code 224-8503
Address 35-1 Chigasakichuo, Tsuzuki Ward, Yokohama, Kanagawa, Japan
TEL +81459497000
Homepage URL
Email ibusiginjp@gmail.com

Sponsor
Institute Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization Cybernet System Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Showa University Northern Yokohama Hospital
Address 35-1 Chigasakichuo, Tsuzuki Ward, Yokohama, Kanagawa, Japan
Tel +81459497000
Email irb02syh@ofc.showa-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

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 13 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 Terminated
Date of protocol fixation
2021 Year 03 Month 20 Day
Date of IRB
2021 Year 04 Month 13 Day
Anticipated trial start date
2021 Year 05 Month 30 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We produce a test data set including 100 positive videos (each video containing one polyp) and 100 negative videos (each video containing no polyp). Study endoscopists view these 200 videos using a web-based testing system and are asked to answer whether each video contains a polyp. After a 4-week interval, they are again asked to repeat the same procedure. However, during the second testing, the 200 videos are tracked by EndoBRAIN-EYE, and areas that are suspicious of having polyps are highlighted by bounding boxes and with the alerting sound.
Each video is presented in a random order in both the first and second assessments.

Management information
Registered date
2021 Year 05 Month 13 Day
Last modified on
2021 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050469

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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