UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040677 |
|---|---|
| Receipt number | R000046427 |
| Scientific Title | A prospective study of computer-aided detection for colonoscopy |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2021/09/14 15:30:56 |
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Basic information
Public title
Evaluation of AI-assisted software for colonoscopy
Acronym
Evaluation of AI software for colon
Scientific Title
A prospective study of computer-aided detection for colonoscopy
Scientific Title:Acronym
A prospective evaluation of CADe
Region
| Japan |
Condition
Condition
colorectal lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the lesion detection rate when using the AI-assisted computer-aided detection system (ENDOBRAIN-EYE).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adenoma detection rate per one colonoscopy
Key secondary outcomes
1. Flat and depressed tumor detection rate per colonoscopy
2. Detection rate of advanced adenoma per colonoscopy
Advanced adenoma is an adenoma of 10 mm or more, histopathologically villous or tubulovillous component, and high-grade dysplasia.
3. Sessile serrated lesion (SSL) detection rate per colonoscopy
4. Diminutive adenoma detection rate
5. Polyp detection rate
6. Mean number of adenomas per procedure (MAP)
7. Total observation time (including treatment time) from reaching the cecum to withdrawal through the anus.
8. Incident rate
9. Medical cost per examination (treatment-related costs/pathological diagnosis costs)
10. Rate of post colonoscopy colorectal cancer and advanced adenoma
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 who underwent colonoscopy at the Digestive Disease Center, Showa University Northern Yokohama Hospital from June 2020 to March 2025
2. Patients aged 20 years or older at the time of colonoscopy.
Key exclusion criteria
1. Patients with prior lesion information
2. Patients with inflammatory bowel disease (including various kinds of colitis except for UC or Chron)
3. Polyposis patient
4. Patients who refuse to use the information they use
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Misawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama City
TEL
045-949-7265
mmisawa@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Misawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
Chigasaki-chuo35-1, Tsuduki-ku, Yokohama City
TEL
0459497265
Homepage URL
mmisawa@med.showa-u.ac.jp
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Chigasaki-chuo 35-1, Tsuduki, Yokohama City
Tel
0459497000
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
| 2020 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0016510721015455
Number of participants that the trial has enrolled
2261
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
Main results already published
Date of protocol fixation
| 2020 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
The colonoscopy performed from June 2020 to March 2025 is the target. The patients have performed the colonoscopy with the standard protocol. After the endoscope reaches the cecum, the doctor presses the analysis start button on the ENDOBRAIN-EYE, and thereafter withdrawal of the endoscope while carefully observing the mucosae. The lesions found during the withdrawal are observed and then the treatment strategy is determined based on the doctor's judgment. If it is determined that the resection of the lesions is necessary, the resection is performed on the same day or at a later date and sent to the pathological diagnosis. The doctor will enter the lesion site, size, and morphology found after the colonoscopy in the medical record as usual. At this time, no new information specific to this study is acquired.
This sequence is the usual practice, with no intervention. ENDOBRAIN-EYE is installed in the 10th, 8th, 7th, and 6th examination rooms of the digestive center endoscopy room, and it operates only on Monday, Wednesday, and Friday due to software maintenance reasons. In this study, the group that did not use ENDOBRAIN-EYE is treated as a comparison.
Management information
Registered date
| 2020 | Year | 06 | Month | 06 | Day |
Last modified on
| 2021 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046427
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