Comparing Diagnostic Accuracy of High-end Intestinal Ultrasound Versus Mid-end Ultrasound With Tandem Ileo-colonoscopy in Inflammatory Bowel Disease : a Paired, Validating Confirmatory Study

The HUMID Study (High-end vs. Mid-end Ultrasound in IBD Diagnostics) is a prospective, cross-sectional, paired diagnostic accuracy study evaluating the performance of mid-end versus high-end intestinal ultrasound (IUS) machines in assessing ileocolonic involvement in patients with inflammatory bowel disease (IBD). Conducted at the Asian Institute of Gastroenterology, this study compares the Siemens ACUSON S2000 (mid-end) with the Samsung RS85 (high-end) ultrasound machines, using ileo-colonoscopy as the reference standard. All enrolled patients will undergo clinical evaluation, IUS with both machines, and colonoscopy. The primary objective is to assess and compare the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of the two ultrasound systems. Secondary objectives include evaluating the impact of IUS findings on clinical management. The study aims to provide evidence for cost-effective imaging strategies in resource-limited settings where access to advanced diagnostics is restricted.

NCT Number	NCT06938295
Lead Sponsor	Asian Institute of Gastroenterology, India
Conditions	Inflammatory Bowel Disease (IBD)
Enrollment	500 participants
Start Date	2024-09-14
Primary Completion	2025-10-30 (estimated)
Study Completion	2025-10-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-16