UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044197 |
|---|---|
| Receipt number | R000047706 |
| 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 05:29:02 |
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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
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Physicians who works at European countries where the European Union Medical Device Regulation (EU-MDR) is valid.
2. Physicians who have experienced at least 50 colonoscopies
3. Those who provide informed consent regarding the participation of the study
*These participants are classified into two categories according to the following criteria
[Less experienced endoscopists]
1. Those who have experienced 50-400 colonoscopies
[Experienced endoscopists]
1. Those who have experienced >400 colonoscopies
Key exclusion criteria
None
Target sample size
30
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
kudos@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Mori |
Organization
University of Oslo / Showa University
Division name
Clinical Effectiveness Research Group
Zip code
0372
Address
Sognsvannsveien 21
TEL
+81459497000
Homepage URL
ibusiginjp@gmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
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
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
Enrolling by invitation
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 | 31 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047706
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
