Unique ID issued by UMIN | UMIN000049054 |
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Receipt number | R000055293 |
Scientific Title | Efficacy of EndoBRAIN-EYE for detection of colorectal neoplasia: an open-label randomized control trial |
Date of disclosure of the study information | 2022/09/28 |
Last modified on | 2023/09/29 09:22:35 |
Efficacy of EndoBRAIN-EYE for detection of colorectal neoplasia: an open-label randomized control trial
EYE-OPENER trial
Efficacy of EndoBRAIN-EYE for detection of colorectal neoplasia: an open-label randomized control trial
EYE-OPENER trial
Japan |
Adenoma
Gastroenterology |
Others
NO
To evaluate the efficacy of EndoBRAIN-EYE for lesion detection during colonoscopy
Efficacy
Adenoma detection rate: ADR
1. Proximal ADR
2. Adenoma per colonoscopy
3. Sessile serrated lesion detection rate: SDR
4. Proximal SDR
5. Sessile serrated lesion per colonoscopy
6. Advanced adenoma detection rate
7. Advanced adenoma per colonoscopy
8. Advanced neoplasia detection rate
9. Advanced neoplasia per colonoscopy
10. Total number of adenomas and sessile serrated lesions
11. Non-neoplastic resection rate
12. Insertion time
13. Observation time
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Device,equipment |
Colonoscopy with EndoBRAIN-EYE
Colonoscopy without EndoBRAIN-EYE
40 | years-old | <= |
Not applicable |
Male and Female
1. 40 years old or more
2. Colonoscopy for CRC screening, post-polypectomy surveillance, FIT positivity, or symptom/signs
3. Consent for polypectomy
1. Patients with a history of CRC (T1 or deeper)
2. Patients with a history of bowel resection
3. Patients with inflammatory bowel disease
4. Patients with colorectal polyposis
5. Patients who take antithrombotic medications and cannot be withdrawn from them
1000
1st name | Yohei |
Middle name | |
Last name | Yabuuchi |
Kobe City Medical Center General Hospital
Department of Gastroenterology
650-0047
2-1-1 Minatojima Minamimachi , Chuo-ku, Kobe
078-302-4321
yohei_yabuuchi@kcho.jp
1st name | Yohei |
Middle name | |
Last name | Yabuuchi |
Kobe City Medical Center General Hospital
Department of Gastroenterology
650-0047
2-1-1 Minatojima Minamimachi , Chuo-ku, Kobe
078-302-4321
yohei_yabuuchi@kcho.jp
Kobe City Medical Center General Hospital
None
Self funding
Kobe City Medical Center General Hospital
2-1-1 Minatojima Minamimachi , Chuo-ku, Kobe
078-302-4321
N/A
NO
2022 | Year | 09 | Month | 28 | Day |
Unpublished
No longer recruiting
2022 | Year | 06 | Month | 28 | Day |
2022 | Year | 08 | Month | 02 | Day |
2022 | Year | 09 | Month | 28 | Day |
2026 | Year | 12 | Month | 31 | Day |
2022 | Year | 09 | Month | 28 | Day |
2023 | Year | 09 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055293
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