UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050685 |
|---|---|
| Receipt number | R000057748 |
| Scientific Title | The usefulness of computer-aided detection technologies based on artificial intelligence with image enhanced endoscopy for detecting colon adenoma; single center, randomized controlled trial |
| Date of disclosure of the study information | 2023/03/27 |
| Last modified on | 2024/09/25 16:35:21 |
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Basic information
Public title
The usefulness of computer-aided detection technologies based on artificial intelligence with image enhanced endoscopy for detecting colon adenoma; single center, randomized controlled trial
Acronym
The usefulness of computer-aided detection technologies based on artificial intelligence with image enhanced endoscopy for detecting colon adenoma; single center, randomized controlled trial
Scientific Title
The usefulness of computer-aided detection technologies based on artificial intelligence with image enhanced endoscopy for detecting colon adenoma; single center, randomized controlled trial
Scientific Title:Acronym
The usefulness of computer-aided detection technologies based on artificial intelligence with image enhanced endoscopy for detecting colon adenoma; single center, randomized controlled trial
Region
| Japan |
Condition
Condition
colon adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the detection rate of colon adenoma by using computer-aided detection technologies with image enhanced endoscopy compared with white light endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adenoma missing rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
LCA/AI-first group
Interventions/Control_2
WLI-first Group
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. adult patients (age 20 or over) presenting for colonoscopy for colorectal cancer (CRC) screening or surveillance
2. patients who gave informed consent after a physician's explanation
Key exclusion criteria
1. Patients with inflammatory bowel disease
2. No history of intestinal resection
3. No history of familial adenomatous polyposis
4. No history of severe intestinal adhesions
5. patients with a BPPS of 0 to 1
6. Patients who are considered ineligible by an attending physician
Target sample size
232
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Goto |
Organization
Nippon Medical School, Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
o-goto@nms.ac.jp
Public contact
Name of contact person
| 1st name | Naohiko |
| Middle name | |
| Last name | Akimoto |
Organization
Nippon Medical School, Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
s03-004an@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
self fund
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
Central Ethics Committee of Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
Tel
03-3822-2131
chuorinri.group@nms.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
| 2023 | Year | 03 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057748
