Tokyo, Jan. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060514) titled 'A Multicenter Retrospective Observational Study on Changes in Detection Accuracy According to Version of Upper Endoscopy Image Diagnosis Support Program for Detection' on Jan. 29.
Study Type:
Observational
Primary Sponsor:
Institute - Wakayama Medical University
Condition:
Condition - Esophageal disease
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to verify the performance of the new version 2.0 of the EW10-EG01 upper endoscopy image diagnosis support program for detection, developed by Fujifilm, from a clinical perspective. Specifically, the EW10-EG01 ver. 1.1 and ver. 2.0 programs will be applied offline and compared using case videos collected in a previous study (UMIN000049887). As a result, we aim to evaluate the effectiveness of the device in improving detection accuracy.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Case videos were recorded for 181 cases (215 lesions) registered in the multi-institutional prospective observational study "Studying the usefulness of an endoscopic image diagnosis support system using artificial intelligence for esophageal cancer" (primary study UMIN000049887).
Key exclusion criteria - Cases of patients who expressed their intention to be excluded from the study after opting out
Cases whose case videos are unsuitable for analysis
Target Size - 181
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 23 Day
Anticipated trial start date - 2025 Year 12 Month 23 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069227
Disclaimer: Curated by HT Syndication.
