Clinical usefulness of observation of colonic mucosa in ulcerative colitis using a new endoscopic system

JRCT ID: jRCTs072200068

Registered date:18/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 28/06/2021
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Observation with a new endoscope system

Outcome(s)

• Primary Outcome: Changes in color of mucous membrane over time by observation of a new endoscopic system

Secondary Outcome

1. Correlation between new endoscopic system observations and other endoscopic activity scores from existing endoscopic systems
2.Correlation between new endoscopic system observation and inflammatory activity markers (CRP, WBC)
3. Correlation between endoscope score and clinical symptoms

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: A person who have a definite diagnosis of ulcerative colitis with Mayo endoscopic score (MES) 1 or over.

Exclude criteria

1)Pregnant or breastfeeding women
2)Patients who have a history of psychosomatic disorders
3)Patients whom investigators considered inappropriate to participate in this study

Related Information

• Primary Sponsor: Kanmura Shuji
• Source(s) of Monetary Support: FUJIFILM Corporation