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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047775
Receipt No. R000054463
Scientific Title Prospective study of whether AI improves the quality of acquired images for endoscopic remission assessment of UC
Date of disclosure of the study information 2022/05/16
Last modified on 2022/05/16

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Basic information
Public title Will AI improve the quality of acquired images for endoscopic remission assessment of UC?
Acronym UC-AI study
Scientific Title Prospective study of whether AI improves the quality of acquired images for endoscopic remission assessment of UC
Scientific Title:Acronym UC-AI studyc
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify whether an AI-equipped endoscopic diagnostic support system (EB-UC2) improves image quality in endoscopic remission assessment by non-experts.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference in acquisition rate of evaluation-inappropriate images with and without the use of EB-UC2
Key secondary outcomes The difference in diagnostic concordance rates of acquired images with and without the use of EB-UC2

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 No use of AI system (EB-UC2) for endoscopic remission assessment of UC
Interventions/Control_2 Use of the AI system (EB-UC2) for endoscopic remission assessment of UC
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria White light endoscopic images that were acquired from the following patients;

Patients who underwent colonoscopy for clinical necessity at Showa University Northern Yokohama Hospital.

Patients undergoing colonoscopy by a non-specialist.

Patients who have given consent to participate in the study.
Key exclusion criteria Images of neoplastic lesions.

Images of the small intestinal mucosa
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yasuharu
Middle name
Last name Maeda
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 224-8503
Address 35-1 Chigasakichuo Tuduki-ku Yokohama
TEL 0459497000
Email yasuharumaeda610@hotmail.com

Public contact
Name of contact person
1st name Yasuharu
Middle name
Last name Maeda
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 224-8503
Address 35-1 Chigasakichuo Tuduki-ku Yokohama
TEL 0459497000
Homepage URL
Email yasuharumaeda610@hotmail.com

Sponsor
Institute Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Showa University Northern Yokohama Hospital
Address 35-1 Chigasakichuo Tuduki-ku Yokohama
Tel +81459497000
Email yasuharumaeda610@hotmail.com

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 05 Month 16 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
2022 Year 01 Month 16 Day
Date of IRB
2022 Year 03 Month 09 Day
Anticipated trial start date
2022 Year 05 Month 16 Day
Last follow-up date
2023 Year 10 Month 10 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 05 Month 16 Day
Last modified on
2022 Year 05 Month 16 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054463

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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