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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000040677
Receipt No. 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

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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
Email 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
Email mmisawa@med.showa-u.ac.jp

Sponsor
Institute Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046427

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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