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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

Study acronym: HUMID
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 16, 2025 (before its estimated October 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Trial status: Active, Not Recruiting to Recruitingv2 Show 4 more changesShow less
    • Enrollment target: 100 to 500
    • Primary completion date: Aug 13, 2025 to Oct 30, 2025
    • Study completion date: Sep 30, 2025 to Oct 30, 2025
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06938295
Lead Sponsor Asian Institute of Gastroenterology, India
Conditions
(from sponsor)
Inflammatory Bowel Disease (IBD)
Related terms Colitis, Ulcerative, Inflammatory Bowel Diseases
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov