UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049719 |
|---|---|
| Receipt number | R000056632 |
| Scientific Title | A Study on Improvement of Accuracy of Assistive Artificial Intelligence for Colonoscopy CADe: Study on Improvement of Accuracy of EndoBRAIN-EYE |
| Date of disclosure of the study information | 2022/12/09 |
| Last modified on | 2022/12/07 17:24:48 |
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Basic information
Public title
A Study on Improvement of Accuracy of Assistive Artificial Intelligence for Colonoscopy CADe:
Study on Improvement of Accuracy of EndoBRAIN-EYE
Acronym
EndoBRAIN challenge study 2
Scientific Title
A Study on Improvement of Accuracy of Assistive Artificial Intelligence for Colonoscopy CADe:
Study on Improvement of Accuracy of EndoBRAIN-EYE
Scientific Title:Acronym
EndoBRAIN challenge study 2
Region
| Japan |
Condition
Condition
Colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy of colorectal polyp detection using computer-aided detection (CADe) in colonoscopy, EndoBRAIN-EYE Ver3.0, and to determine how much the accuracy has improved compared to the previous EndoBRAIN-EYE Ver1.2.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Colorectal lesion detection rate and accuracy (positive diagnosis rate, sensitivity, specificity, positive predictive value, negative predictive value)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients 20 years of age or older undergoing total colonoscopy
(2) Patients who fully understand this clinical study and are capable of obtaining consent
(3) Patients whose lesion information is not clear before the examination and who do not meet any of the exclusion criteria.
Key exclusion criteria
1) Patients with a history of surgery involving colorectal resection other than appendicectomy
2)Patients with complicated inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.)
3)Patients with more than 6 polyps or complicated colorectal polyposis or hereditary non-polyposis colorectal cancer
4)Patients taking antiplatelet or anticoagulant drugs
5)Pregnant, lactating, or possibly pregnant at the time of examination
6)Patients with other more serious concurrent illnesses, etc., for which the physician in charge determines that the patient is not suitable for the procedure.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Sugimura |
Organization
Sano hospital
Division name
Gastroenterology Center
Zip code
655-0031
Address
2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Japan
TEL
078-785-1000
n-sugimura@sano-hospital.or.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Sugimura |
Organization
Sano hospital
Division name
Gastroenterology Center
Zip code
655-0031
Address
2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Japan
TEL
078-785-1000
Homepage URL
n-sugimura@sano-hospital.or.jp
Sponsor or person
Institute
Sano hospital
Institute
Department
Personal name
Funding Source
Organization
Sano hospital
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
Sano hospital
Address
2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Japan
Tel
078-785-1000
n-sugimura@sano-hospital.or.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
| 2022 | Year | 12 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2022 | Year | 12 | Month | 07 | Day |
Last modified on
| 2022 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056632
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
