Tokyo, March 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060943) titled 'Prospective follow-up study of small bowel involvement using capsule endoscopy in newly diagnosed CD patients (PASSAGE-CD)' on March 16.

Study Type: Observational

Primary Sponsor: Institute - Saga University

Condition: Condition - Crohn's disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to clarify the clinical significance of small intestinal lesions, particularly those characteristic of early-stage CD, by tracking their serial progression using SBCE from the time of the initial CD diagnosis. Basic objectives2 - Safety

Eligibility: Age-lower limit - 12 years-old

Gender - Male and Female Key inclusion criteria - 1. Patients who have not yet started advanced treatment within two years of receiving a definitive diagnosis of Crohn's disease 2. Patients who have not received a definitive diagnosis of Crohn's disease but are strongly suspected of having it Key exclusion criteria - 1. Patients in whom gastrointestinal patency cannot be confirmed using a pre-examination patency capsule 2. Patients with gastrointestinal fistulas 3. Patients with gastrointestinal motility disorders 4. Patients under 12 years of age or 75 years of age or older 5. Patients with an implanted pacemaker 6. Patients taking NSAIDs (including aspirin) on a regular basis 7. Individuals with concurrent malignant tumors, psychiatric disorders, or severe (very serious) liver, kidney, heart, or hematopoietic system disorders 8. Pregnant women, women who may be pregnant, breastfeeding women, or women who wish to become pregnant during the study period 9. Any other cases where the study investigator determines that participation in this study is inappropriate Target Size - 135

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 09 Month 11 Day Date of IRB - 2025 Year 12 Month 24 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2033 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069747

Disclaimer: Curated by HT Syndication.