Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062517) titled 'The study of AI based Vascular healing in disease monitoring of UC: a multi-center prospective cohort study' on Aug. 7.
Study Type:
Observational
Primary Sponsor:
Institute - Showa Medical University
Condition:
Condition - Ulcerative colitis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the predictive performance and risk stratification ability of an artificial intelligence based narrow band imaging system for relapse within 12 months as a clinically important outcome
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Age 18 years or older
2. Confirmed diagnosis of ulcerative colitis
3. Steroid-free clinical remission, defined as a partial Mayo score of 1 or less, maintained for at least 6 months
4. Scheduled to undergo colonoscopy based on clinical necessity
Key exclusion criteria - 1. Unable to provide informed consent
2. Contraindication to colonoscopy or biopsy
3. Inadequate bowel preparation
4. Serious comorbidities
5. Pregnancy or breastfeeding
6. Change or escalation of treatment within the previous 3 months
7. Ulcerative proctitis
8. Considered unsuitable for participation by the investigator
Target Size - 300
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 05 Month 07 Day
Date of IRB - 2026 Year 07 Month 31 Day
Anticipated trial start date - 2026 Year 08 Month 07 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=R000071549
Disclaimer: Curated by HT Syndication.
