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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

RecruitingNAAges 18 Years - 75 YearsAllAsian Institute of Gastroenterology, India
NCT06938295 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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
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What it tests

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

1 site
Asian Institute of Gastroenterology
Hyderabad, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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