UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046361 |
|---|---|
| Receipt number | R000052900 |
| Scientific Title | A randomized control trial of adenoma detection rate in artificial intelligence-assisted colonoscopy using linked color imaging |
| Date of disclosure of the study information | 2021/12/13 |
| Last modified on | 2024/12/15 22:28:15 |
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Basic information
Public title
A randomized control trial of adenoma detection rate in artificial intelligence-assisted colonoscopy using linked color imaging
Acronym
ADR by AI in LCI-colonoscopy
Scientific Title
A randomized control trial of adenoma detection rate in artificial intelligence-assisted colonoscopy using linked color imaging
Scientific Title:Acronym
ADR by AI in LCI-colonoscopy
Region
| Japan |
Condition
Condition
colonic adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to analyze of efficacy of artificial intelligence to adenoma detection rate in colonoscopy using linked color imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adenoma detection rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
artificial intelligence
Interventions/Control_2
no artificial intelligence
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
Patients with positive occult blood test, follow-up of colonic polyp or abdominal symptom
Key exclusion criteria
no preparation
ileus, stenosis, fistula, history of colonic surgery, IBD, diverticulitis
alcoholism
hyperthyroidosis
severe heart failure, liver disease or renal dysfunction
pregnancy
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Imaeda |
Organization
Saitama Medical University Hospital
Division name
Department of Gastroenterology
Zip code
350-0495
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
TEL
0492761667
imaedahi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Imaeda |
Organization
Saitama Medical University Hospital
Division name
Department of Gastroenterology
Zip code
350-0495
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
TEL
0492761667
Homepage URL
imaedahi@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
Saitama Medical University Hospital
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
Tel
0492761111
hirb@saitama-med.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
| 2021 | Year | 12 | Month | 13 | 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
800
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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052900
