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 · NCT06938295 · Interventional (participants receive a specific treatment) · Lead sponsor: Asian Institute of Gastroenterology, India

View the official record on ClinicalTrials.gov →

Ulcerative colitis

Interventions studied

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

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.

Who can take part

Age range

18 Years to 75 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

1 location listed.

Asian Institute of Gastroenterology - Hyderabad, Telangana, India

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →