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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000046599 |
Receipt No. | R000053122 |
Scientific Title | A multicenter study for gastric lesion detection performance of Computer-Aided-Detection (CADe) program for endoscopy |
Date of disclosure of the study information | 2022/01/24 |
Last modified on | 2022/01/11 |
Basic information | ||
Public title | Performance evaluation of computer-Aided gastric lesion detection program with artificial intelligence (AI) for endoscopy | |
Acronym | Performance evaluation of computer-Aided gastric lesion detection program for endoscopy | |
Scientific Title | A multicenter study for gastric lesion detection performance of Computer-Aided-Detection (CADe) program for endoscopy | |
Scientific Title:Acronym | Performance evaluation of endoscopy CADe program | |
Region |
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Condition | ||
Condition | Localized gastric lesions | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the gastric lesion detection performance of the endoscopy CADe program |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Sensitivity of the CADe program for detecting the gastric lesions |
Key secondary outcomes | Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the total frames of gastric lesions to be analyzed |
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 | |
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Interventions/Control_9 | |
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 | Patients who undergo upper gastrointestinal endoscopy at the institutions during the study period. | |||
Key exclusion criteria | Patients who:
- underwent total gastrectomy; - are under the age of 20; - do not agree to participate in this study; - cannot follow instructions of this study and endoscopy and; - are judged to be inappropriate as a subject of this study by the investigator, for other reasons. |
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Target sample size | 267 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Fukuoka University Chikushi Hospital | ||||||
Division name | Department of Endoscopy | ||||||
Zip code | 818-8502 | ||||||
Address | 1-1-1 Zokumyoin, Chikushino-shi, Fukuoka | ||||||
TEL | 092-921-101 | ||||||
yao@fukuoka-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Fukuoka University Chikushi Hospital | ||||||
Division name | Department of Endoscopy | ||||||
Zip code | 818-8502 | ||||||
Address | 1-1-1 Zokumyoin, Chikushino-shi, Fukuoka | ||||||
TEL | 092-921-1011 | ||||||
Homepage URL | |||||||
yao@fukuoka-u.ac.jp |
Sponsor | |
Institute | Fukuoka University Chikushi Hospital |
Institute | |
Department |
Funding Source | |
Organization | OLYMPUS Medical Systems Corp |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Fukuoka University-Medical Ethics Review Board |
Address | 7-45-1 Nanakuma, Jonan-kuFukuoka 814-0180, JAPAN |
Tel | 092-801-1011 |
fumed-ethics@fukuoka-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 | 静岡がんセンター(静岡県)、千葉大学医学部附属病院(千葉県)、
神戸市立医療センター中央市民病院(兵庫県)、 オリンパスメディカルシステムズ株式会社(東京都) |
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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | A total of three institutes participating in this joint study including Fukuoka University Chikushi Hospital perform upper gastrointestinal endoscopy. The performance of the endoscopy CADe program is evaluated with videos, which are recorded during the endoscopy after obtaining informed consent from the patients. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053122 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |