Actively Recruiting
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
Led by Asian Institute of Gastroenterology, India · Updated on 2025-07-16
500
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18-75 years
- Confirmed diagnosis of inflammatory bowel disease (IBD) with ileocolonic involvement
- Clinically stable at the time of assessment
- Willing and able to undergo both mid-end and high-end intestinal ultrasound assessments and ileo-colonoscopy
- Provides informed consent to participate in the study
You will not qualify if you...
- Pregnant or breastfeeding individuals
- Contraindications to ileo-colonoscopy such as severe comorbidities or known intolerance
- Unable to provide informed consent
- Conditions interfering with ultrasound imaging, including severe obesity or uncooperative behaviour
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Asian Institute of Gastroenterology
Hyderabad, Telangana, India, 500082
Actively Recruiting
Research Team
P
Partha Pal, MD, DNB, MRCP (UK), FASGE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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