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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000040677 |
Receipt No. | R000046427 |
Scientific Title | A prospective study of computer-aided detection for colonoscopy |
Date of disclosure of the study information | 2020/12/01 |
Last modified on | 2020/07/24 |
Basic information | ||
Public title | Evaluation of AI-assisted software for colonoscopy | |
Acronym | Evaluation of AI software for colon | |
Scientific Title | A prospective study of computer-aided detection for colonoscopy | |
Scientific Title:Acronym | A prospective evaluation of CADe | |
Region |
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Condition | ||
Condition | colorectal lesion | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the lesion detection rate when using the AI-assisted computer-aided detection system (ENDOBRAIN-EYE). |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Adenoma detection rate per one colonoscopy |
Key secondary outcomes | 1. Flat and depressed tumor detection rate per colonoscopy
2. Detection rate of advanced adenoma per colonoscopy Advanced adenoma is an adenoma of 10 mm or more, histopathologically villous or tubulovillous component, and high-grade dysplasia. 3. Sessile serrated lesion (SSL) detection rate per colonoscopy 4. Diminutive adenoma detection rate 5. Polyp detection rate 6. Mean number of adenomas per procedure (MAP) 7. Total observation time (including treatment time) from reaching the cecum to withdrawal through the anus. 8. Incident rate 9. Medical cost per examination (treatment-related costs/pathological diagnosis costs) 10. Rate of post colonoscopy colorectal cancer and advanced adenoma |
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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Patients who underwent colonoscopy at the Digestive Disease Center, Showa University Northern Yokohama Hospital from June 2020 to March 2025
2. Patients aged 20 years or older at the time of colonoscopy. |
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Key exclusion criteria | 1. Patients after colectomy
2. Patients with inflammatory bowel disease (including various kinds of colitis except for UC or Chron) 3. Polyposis patient 4. Patients who refuse to use the information they use |
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Target sample size | 10000 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Showa University Northern Yokohama Hospital | ||||||
Division name | Digestive Disease Center | ||||||
Zip code | 224-8503 | ||||||
Address | Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama City | ||||||
TEL | 045-949-7265 | ||||||
mmisawa@med.showa-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Showa University Northern Yokohama Hospital | ||||||
Division name | Digestive Disease Center | ||||||
Zip code | 224-8503 | ||||||
Address | Chigasaki-chuo35-1, Tsuduki-ku, Yokohama City | ||||||
TEL | 0459497265 | ||||||
Homepage URL | |||||||
mmisawa@med.showa-u.ac.jp |
Sponsor | |
Institute | Digestive Disease Center, Showa University Northern Yokohama Hospital |
Institute | |
Department |
Funding Source | |
Organization | Japan Society for the Promotion of Science |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Showa University Northern Yokohama Hospital |
Address | Chigasaki-chuo 35-1, Tsuduki, Yokohama City |
Tel | 0459497000 |
irb02syh@ofc.showa-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 |
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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 |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information | The colonoscopy performed from June 2020 to March 2025 is the target. The patients have performed the colonoscopy with the standard protocol. After the endoscope reaches the cecum, the doctor presses the analysis start button on the ENDOBRAIN-EYE, and thereafter withdrawal of the endoscope while carefully observing the mucosae. The lesions found during the withdrawal are observed and then the treatment strategy is determined based on the doctor's judgment. If it is determined that the resection of the lesions is necessary, the resection is performed on the same day or at a later date and sent to the pathological diagnosis. The doctor will enter the lesion site, size, and morphology found after the colonoscopy in the medical record as usual. At this time, no new information specific to this study is acquired.
This sequence is the usual practice, with no intervention. ENDOBRAIN-EYE is installed in the 10th, 8th, 7th, and 6th examination rooms of the digestive center endoscopy room, and it operates only on Monday, Wednesday, and Friday due to software maintenance reasons. In this study, the group that did not use ENDOBRAIN-EYE is treated as a comparison. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046427 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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