Prospective observational study on the clinical feasibility of a novel AI system for assessing inflammatory activity in ulcerative colitis.

Prospective observational study on the clinical feasibility of a novel AI system for assessing inflammatory activity in ulcerative colitis. - Prospective observational study on the clinical feasibility of a novel AI system for assessing inflammatory activity in ulcerative colitis.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060073

Enrollment

300

Registered

2025-12-12

Start date

2025-12-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the agreement between the AI-based assessment (UCEGS) and the diagnosis made by IBD experts using the Mayo Endoscopic Subscore (MES), which serves as the gold standard, by calculating Cohen's kappa coefficient. Expert diagnosis: MES 0-1 is defined as remission, and MES 2-3 is defined as active. AI diagnosis: a UCEGS value <5.3 is defined as remission, and a value >=5.3 is defined as active.	—

Measure

Time frame

To evaluate the agreement between the AI-based assessment (UCEGS) and the diagnosis made by IBD experts using the Mayo Endoscopic Subscore (MES), which serves as the gold standard, by calculating Cohen's kappa coefficient. Expert diagnosis: MES 0-1 is defined as remission, and MES 2-3 is defined as active. AI diagnosis: a UCEGS value <5.3 is defined as remission, and a value >=5.3 is defined as active.

—

Secondary

Measure	Time frame
Correlation and agreement between the AI assessment (UCEGS) and histological evaluation. Correlation between clinical outcomes and changes in UCEGS values over time.	—

Countries

Japan

Contacts

Public ContactShoma Murata

Keio University School of Medicine, Tokyo, Japan Division of Gastroenterology and Hepatology, Department of Internal Medicine

shomamurata@keio.jp03-3353-1211

Outcome results