UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051437 |
|---|---|
| Receipt number | R000058532 |
| Scientific Title | A multicenter prospective randomized controlled trial evaluating the usefulness of a real-time colonoscopy diagnostic support system |
| Date of disclosure of the study information | 2023/06/25 |
| Last modified on | 2023/06/23 10:52:21 |
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Basic information
Public title
A multicenter prospective randomized controlled trial evaluating the usefulness of a real-time colonoscopy diagnostic support system
Acronym
eardrum study
Scientific Title
A multicenter prospective randomized controlled trial evaluating the usefulness of a real-time colonoscopy diagnostic support system
Scientific Title:Acronym
eardrum study
Region
| Japan |
Condition
Condition
Colorectal Neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to evaluate whether an increase in the adenoma detection rate can be expected by using an AI system that supports the detection of lesions in real time during colonoscopy, and to examine the usefulness of AI system at multiple centers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Adenoma Detection Rate
Key secondary outcomes
1 ) Polyp Detection Rate
2 ) Adenoma per Positive Colonoscopy
3 ) Rate of increase in ADR by colonoscopy experience
4 ) Detection rate by lesion (size (6 mm or more, less than 6 mm), macroscopic type, location)
5 ) Sessile Serrated Lesion detection rate
6 ) Total procedure time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Using an AI system during colonoscopy.
Interventions/Control_2
Do not use an AI system during colonoscopy.
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
| 35 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who undergo colonoscopy
2) Age:35 to 75 (at the registry)
3) Patients who can follow Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment
4) Written informed consent
Key exclusion criteria
1) Patients who underwent total colonoscopy within 2 years (24 months)
2) Patients with prior colectomy other than appendectomy
3) GI polyposis
4) Patients with complications, such as chronical hematological disease
5) Patients with active inflammatory bowel diseases, such as ulcerative colitis or Crohn's disease
6) pregnant patient
Target sample size
620
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Nishikawa |
Organization
Toho University Oomori hospital
Division name
Departments of Gastroenterology
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
yuusuke.nishikawa@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Nishikawa |
Organization
Toho University Oomori hospital
Division name
Departments of Gastroenterology
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
Homepage URL
yuusuke.nishikawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Oomori hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Health Promotion Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Toho University Omori Hospital
Address
6-11-1 Omorinishi, Ota-ku, Tokyo, Japan
Tel
03-5763-6534
omori.rinri@ext.toho-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
東邦大学大森病院（東京都）、東京労災病院（東京都）、関東労災病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 05 | 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
| 2023 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058532
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| Registered date | File name |
| Research case data | |
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