Unique ID issued by UMIN | UMIN000044196 |
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Receipt number | 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 05:18:13 |
Bench-mark test for assessment of EndoBRAIN-EYE in the European setting
Euro-EndoBRAIN-EYE
Bench-mark test for assessment of EndoBRAIN-EYE in the European setting
Euro-EndoBRAIN-EYE
Europe |
Premarket retrospective study (Multi-reader, multi-case study [MRMC])
Gastroenterology |
Others
NO
To evaluate the efficacy of the automated polyp detection system (EndoBRAIN-EYE) for colonoscopy under the intended use condition.
Efficacy
Whether EndoBRAIN-EYE increases the sensitivity of polyp detection by less experienced endoscopists
Others,meta-analysis etc
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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
None
20
1st name | Shin-ei |
Middle name | |
Last name | Kudo |
Showa University Northern Yokohama Hospital
Digestive Disease Center
224-8503
35-1 Chigasakichuo, Tsuzuki Ward, Yokohama, Kanagawa, Japan
+81459497000
kudos@med.showa-u.ac.jp
1st name | Yuichi |
Middle name | |
Last name | Mori |
Showa University Northern Yokohama Hospital / University of Oslo
Digestive Disease Center
224-8503
35-1 Chigasakichuo, Tsuzuki Ward, Yokohama, Kanagawa, Japan
+81459497000
ibusiginjp@gmail.com
Showa University Northern Yokohama Hospital
Cybernet System Corporation
Profit organization
Showa University Northern Yokohama Hospital
35-1 Chigasakichuo, Tsuzuki Ward, Yokohama, Kanagawa, Japan
+81459497000
irb02syh@ofc.showa-u.ac.jp
NO
2021 | Year | 05 | Month | 13 | Day |
Unpublished
Terminated
2021 | Year | 03 | Month | 20 | Day |
2021 | Year | 04 | Month | 13 | Day |
2021 | Year | 05 | Month | 30 | Day |
2022 | Year | 12 | Month | 31 | Day |
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.
2021 | Year | 05 | Month | 13 | Day |
2021 | Year | 05 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050469
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