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

Recruiting now · Not applicable

Conditions studied: Inflammatory Bowel Disease (IBD)

In brief

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.

Key facts

Study ID

NCT06938295

Run by

Asian Institute of Gastroenterology, India

People needed

500

Starts

2024-09-14

Expected to finish

2025-10-30

Last updated by the study team

2025-07-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18-75 years.
• Confirmed diagnosis of inflammatory bowel disease (IBD), specifically with ileocolonic involvement.
• Clinically stable at the time of assessment.
• Willing and able to undergo both intestinal ultrasound (IUS) assessments (mid-end and high-end) and the reference standard ileo-colonoscopy.
• Provides informed consent to participate in the study.

You may not qualify if…

• Pregnant or breastfeeding individuals.
• Patients with contraindications to ileo-colonoscopy (e.g., severe comorbidities, known intolerance).
• Individuals unable to provide informed consent.
• Patients with conditions interfering with ultrasound imaging, such as severe obesity or uncooperative behaviour

Where it is running

• Asian Institute of Gastroenterology — Hyderabad, Telangana, India (enrolling)

Full record on ClinicalTrials.gov

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