NCT06938295Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 16 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 21 Nov 2024
- Start date
- 14 Sept 2024
- Primary completion date
- 30 Oct 2025
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06938295
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 14 Sept 2024 to the primary completion date, 30 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with conditions interfering with ultrasound imaging, such as severe obesity or uncooperative behaviour
Other
- Pregnant or breastfeeding individuals.
- Patients with contraindications to ileo-colonoscopy (e.g., severe comorbidities, known intolerance).
- Individuals unable to provide informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asian Institute Of Gastroenterology Coordinator of this site? Confirm its status | Hyderabad | India | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.