NCT06938295 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
| NCT ID | NCT06938295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asian Institute of Gastroenterology, India |
| Condition | Inflammatory Bowel Disease (IBD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-09-14 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2024-09-14 with a primary completion date of 2025-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06938295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Inflammatory Bowel Disease (IBD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06938295 currently recruiting?
Yes, NCT06938295 is actively recruiting participants. Contact the research team at partha0123456789@gmail.com for enrollment information.
Where is the NCT06938295 trial being conducted?
This trial is being conducted at Hyderabad, India.
Who is sponsoring the NCT06938295 clinical trial?
NCT06938295 is sponsored by Asian Institute of Gastroenterology, India. The trial plans to enroll 500 participants.