UMIN-CTR Clinical Trial

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 after colectomy 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	10000

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	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	Open public recruiting
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	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
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	2020 Year 07 Month 24 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
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Research case data
Registered date	File name

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