UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049054 |
|---|---|
| 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 | 2025/10/01 17:40:24 |
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Basic information
Public title
Efficacy of EndoBRAIN-EYE for detection of colorectal neoplasia: an open-label randomized control trial
Acronym
EYE-OPENER trial
Scientific Title
Efficacy of EndoBRAIN-EYE for detection of colorectal neoplasia: an open-label randomized control trial
Scientific Title:Acronym
EYE-OPENER trial
Region
| Japan |
Condition
Condition
Adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of EndoBRAIN-EYE for lesion detection during colonoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adenoma detection rate: ADR
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Colonoscopy with EndoBRAIN-EYE
Interventions/Control_2
Colonoscopy without EndoBRAIN-EYE
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 40 years old or more
2. Colonoscopy for CRC screening, post-polypectomy surveillance, FIT positivity, or symptom/signs
3. Consent for polypectomy
Key exclusion criteria
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
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Yabuuchi |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Gastroenterology
Zip code
650-0047
Address
2-1-1 Minatojima Minamimachi , Chuo-ku, Kobe
TEL
078-302-4321
yohei_yabuuchi@kcho.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Yabuuchi |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Gastroenterology
Zip code
650-0047
Address
2-1-1 Minatojima Minamimachi , Chuo-ku, Kobe
TEL
078-302-4321
Homepage URL
yohei_yabuuchi@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe City Medical Center General Hospital
Address
2-1-1 Minatojima Minamimachi , Chuo-ku, Kobe
Tel
078-302-4321
N/A
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
| 2022 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1041
Results
ADR was 54.5% in the control group and 50.7% in the CADe group, with no significant difference between the groups (adjusted risk ratio, 0.93; 95% confidence interval [CI], 0.83-1.05). The mean number of APC was lower in the CADe group than in the control group (1.34 vs. 1.14) (adjusted rate ratio, 0.86; 95% CI, 0.77-0.96). The mean withdrawal time was longer in the CADe group than in the control group (691 vs. 751 s, p = 0.034).
Results date posted
| 2025 | Year | 10 | Month | 01 | Day |
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055293
