Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059857) titled 'Development and Performance Validation of Artificial Intelligence-Assisted Image Analysis Software for the Diagnosis of Gastric Intestinal Metaplasia' on Dec. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - International University of Health and Welfare
Condition:
Condition - gastric intestinal metaplasia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to develop and validate an AI-assisted image analysis software for the diagnosis of gastric intestinal metaplasia.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Two biopsies of the gastric mucosa for histopathological confirmation of intestinal metaplasia.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients aged 18 years or older.
2. Patients who meet either of the following conditions (i) or (ii):
(i) Patients diagnosed with atrophic gastritis (AG) or intestinal metaplasia (IM) in previous endoscopic examinations.
(ii) Patients currently infected with Helicobacter pylori or who have undergone eradication therapy in the past.
3. Patients from whom written informed consent for participation in this study has been obtained.
Key exclusion criteria - 1. Patients who are unable to discontinue antithrombotic medication.
2. Pregnant women or women who may be pregnant.
3. Others.
Target Size - 400
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 13 Day
Date of IRB - 2025 Year 11 Month 14 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067974
Disclaimer: Curated by HT Syndication.
