UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044890 |
|---|---|
| Receipt number | R000051271 |
| Scientific Title | A Study of the Usefulness of an AI (Artificial Intelligence) Automated Endoscopic Diagnosis System in Colonoscopy - A Prospective Non-Randomized Controlled Trial (Non-Inferiority Study) |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2024/07/20 00:10:52 |
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Basic information
Public title
A Study of the Usefulness of an AI (Artificial Intelligence) Automated Endoscopic Diagnosis System in Colonoscopy - A Prospective Non-Randomized Controlled Trial (Non-Inferiority Study)
Acronym
Usefulness of AI (Artificial Intelligence) in Colonoscopy
Scientific Title
A Study of the Usefulness of an AI (Artificial Intelligence) Automated Endoscopic Diagnosis System in Colonoscopy - A Prospective Non-Randomized Controlled Trial (Non-Inferiority Study)
Scientific Title:Acronym
A prospective study of CADe
Region
| Japan |
Condition
Condition
colorectal lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify that a non-expert can detect polyps as well as a expert using AI-assisted computer-aided detection system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Polyp detection rate of non-experts with AI-assisted computer-aided detection system is non-inferior to that of experts.
Key secondary outcomes
1. Mean number of adenomas per procedure
2. Polyp detection rate
3. Total procedure time
4. Insertion time
5. Withdrawal time
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients with polyps who have undergone colonoscopy by a expert in the previous year and polyps are not treated and are under observation
(2) Age: 20 to 90 years old (age at the time of registration)
(3) PS: ECOG performance status score: 0 to 2
(4) Patients who have not been previously treated for colorectal lesions, including endoscopic treatment.
(5) Patients who can follow Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment
(6) Patients who have given written consent to participate in the study.
Key exclusion criteria
(1) Patients scheduled for endoscopic treatment of the target lesion
(2) Patients who are judged by the physician in charge to have a bleeding tendency
(3) Patients who deviate from or are unable to comply with the "Guidelines for Gastrointestinal Endoscopy for Patients Taking Antithrombotic Drugs".
(4) Patients with inflammatory bowel disease or familial adenomatous polyposis.
(5) Patients who are judged inappropriate by the investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yasuda |
Organization
St. Marianna University School of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
hyasuda@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadateru |
| Middle name | |
| Last name | Maehata |
Organization
St. Marianna University School of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
Homepage URL
t2maehata@marianna-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
0449778111
k-sienbu.mail@marianna-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
| 2021 | Year | 08 | 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
120
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
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | 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
Prospective, single-center, comparative observational study (comparison with colonoscopy performed in the previous year)
Evaluate the non-inferiority of the polyp detection rate of non-experts using CADe to the detection rate of experts (100%) in patients with polyps who had colonoscopy performed by experts in the previous year.
Management information
Registered date
| 2021 | Year | 07 | Month | 17 | Day |
Last modified on
| 2024 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051271
