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

NARecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

September 14, 2024

Primary Completion Date

October 30, 2025

Study Completion Date

October 30, 2025

Conditions
Inflammatory Bowel Disease (IBD)
Interventions
DIAGNOSTIC_TEST

Comparative Use of High-End and Mid-End Intestinal Ultrasound Devices for IBD Disease activity assessment

This study compares two intestinal ultrasound (IUS) devices-a high-end machine (Samsung RS85) and a mid-end machine (Siemens ACUSON S2000)-for assessing ileocolonic inflammation in IBD patients. The high-end device offers advanced imaging features, including high-resolution, speckle reduction, and extended field of view, allowing for detailed visualization of the bowel wall and vascularity. The mid-end device, while more basic, provides essential IUS functions for examining bowel wall thickness, structure, and inflammation markers. Both devices are used in a single clinical session, with results compared against tandem ileo-colonoscopy as the reference standard. This unique dual approach enables evaluation of the diagnostic performance of each device type. If comparable, the mid-end device may offer a cost-effective solution, increasing access to routine IUS in various healthcare settings, especially where high-end technology is limited.

Trial Locations (1)

500082

RECRUITING

Asian Institute of Gastroenterology, Hyderabad

All Listed Sponsors
lead

Asian Institute of Gastroenterology, India

OTHER