Comparing Diagnostic Accuracy of High-End Intestinal Ultrasound Versus Mid-End Ultrasound With Tandem Ileo-Colonoscopy in Inflammatory Bowel Disease (The HUMID Study): A Paired, Validating Confirmatory Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
India
Asian Institute of Gastroenterology
RECRUITING
Hyderabad
Contact Information
Primary
Partha Pal, MD, DNB, MRCP (UK), FASGE
partha0123456789@gmail.com
+91-8945906823
Time Frame
Start Date: 2024-09-14
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 500
Treatments
Active_comparator: Adult patients with inflammatory bowel disease
Participants will undergo intestinal ultrasound (IUS) assessments using both a high-end (Samsung RS85) and a mid-end (Siemens ACUSON S2000) ultrasound machine to evaluate ileocolonic inflammation in inflammatory bowel disease (IBD). Each device is used within the same session, focusing on bowel wall thickness, vascularity, and structural changes. The high-end ultrasound provides advanced imaging capabilities, while the mid-end device offers standard IUS functionalities. Tandem ileo-colonoscopy is performed as the reference standard to validate findings.~Primary Outcome: Diagnostic accuracy (sensitivity, specificity) of high-end vs. mid-end ultrasound.~Secondary Outcome: Impact of ultrasound findings on clinical management decisions, evaluating cost-effective options for routine IBD monitoring.
Sponsors
Leads: Asian Institute of Gastroenterology, India

This content was sourced from clinicaltrials.gov