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
Not applicable · Testing Comparative Use of High-End and Mid-End Intestinal Ultrasound Devices for IBD Disease… · 1 site · Asian Institute of Gastroenterology, India
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Comparative Use of High-End and Mid-End Intestinal Ultrasound Devices for IBD Disease activity assessment (a diagnostic test) as a way to diagnose or measure disease. Condition(s) listed: Inflammatory Bowel Disease (IBD).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- Patients aged 18-75 years.
- Confirmed diagnosis of inflammatory bowel disease (IBD), specifically with ileocolonic involvement.
- Clinically stable at the time of assessment.
Plus 2 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 500 participants are expected to take part.
- Start date: 2024-09-14.
- Main results expected around 2025-10-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in India.
Main thing being measured
- Diagnostic Accuracy of Mid-End and High-End Ultrasound in Detecting Ileocolonic Inflammation Compared to Ileo-Colonoscopy (Day 1 (same day as colonoscopy))
In the researchers’ words
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).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease (IBD) |
| Lead sponsor | Asian Institute of Gastroenterology, India |
| Enrollment | 500 (estimated) |
| Start date | 2024-09-14 |
| Primary completion (est.) | 2025-10-30 |
| First posted | 2025-04-22 |
| Last updated | 2025-07-16 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06938295 |
Interventions
- Comparative Use of High-End and Mid-End Intestinal Ultrasound Devices for IBD Disease activity assessment (Diagnostic Test)
This study compares two intestinal ultrasound (IUS) devices-a high-end machine (Samsung RS85) and a mid-end machine (Siemens ACUSON S2000)-for assessing ileocolonic inflammation in IBD patients. The high-end device offers advanced imaging features, including high-resolution, speckle reduction, and extended field of view, allowing for detailed visualization of the bowel wall and vascularity. The mi…
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Asian Institute of Gastroenterology | Hyderabad, Telangana | India | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.