Tokyo, Dec. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060073) titled 'Prospective observational study on the clinical feasibility of a novel AI system for assessing inflammatory activity in ulcerative colitis' on Dec. 12.

Study Type: Observational

Primary Sponsor: Institute - Keio University School of Medicine

Condition: Condition - Ulcerative colitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Assessing endoscopic inflammation in ulcerative colitis (UC) is challenging because the mucosal appearance varies widely depending on the degree of inflammation. In current clinical practice, endoscopists evaluate inflammatory activity using scoring systems such as the Mayo Endoscopic Subscore (MES) and the Ulcerative Colitis Endoscopic Index of Severity (UCEIS); however, substantial inter-observer variability and limited intra-observer reproducibility remain well-recognized issues. To enable more objective and accurate assessment in daily practice, we have developed a novel artificial intelligence (AI) system capable of grading inflammatory severity on a continuous 0-10 scale, termed the Ulcerative Colitis Endoscopic Gradation Scale (UCEGS). Unlike conventional scoring systems, this AI model evaluates the degree of inflammation itself without being constrained by predefined categorical criteria. In preclinical validation using selected high-quality images, the AI-derived UCEGS demonstrated strong concordance with assessments by IBD experts, with a Spearman correlation coefficient exceeding 0.95. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients diagnosed with ulcerative colitis who are scheduled to undergo lower gastrointestinal endoscopy. Patients aged 18 years or older at the time of consent. Patients who can provide written informed consent to participate in this study. Key exclusion criteria - Patients with a history of total colectomy. Patients deemed inappropriate for participation in this study at the discretion of the investigator. Patients who withdraw their consent to participate in the study after registration. Target Size - 300

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 07 Month 01 Day Date of IRB - 2025 Year 07 Month 01 Day Anticipated trial start date - 2025 Year 12 Month 12 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=R000068680

Disclaimer: Curated by HT Syndication.