Calculating the LEmann IndeX Using InTEstiNal Ultrasound
Observational · No treatment assigned · Sites not listed yet · International Bowel Ultrasound Group e.V.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease (CD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any Screening procedures.
- Patients with a previously documented CD diagnosis confirmed by clinical, endoscopic, histological, and/or radiological criteria.
- Age ≥18 years old.
Plus 1 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 102 participants are expected to take part.
- Start date: 2024-12 (planned).
- Main results expected around 2025-12 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Intraclass correlation between the LI-IUS scores and the LI-MRE scores assessing small bowel damage and colon damage in patients with CD. (Baseline)
In the researchers’ words
The goal of this clinical trial is to assess and quantitatively measure structural bowel damage in Crohn's disease (CD) with the Lèmann-Index (LI) for Intestinal Ultrasound (IUS). IUS is a non-invasive, easily repeated and well tolerated tool with no bowel preparations.
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 | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease (CD) |
| Lead sponsor | International Bowel Ultrasound Group e.V. |
| Collaborators | The Leona M. and Harry B. Helmsley Charitable Trust |
| Enrollment | 102 (estimated) |
| Start date | 2024-12 |
| Primary completion (est.) | 2025-12 |
| First posted | 2024-10-18 |
| Last updated | 2024-10-23 |
| Official title | Calculating the LEmann IndeX Using InTEstiNal Ultrasound |
| ClinicalTrials.gov ID | NCT06647823 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any Screening procedures. * Patients with a previously documented CD diagnosis confirmed by clinical, endoscopic, histological, and/or radiological criteria. * Age ≥18 years old. * Examinations needed as standard of care. Exclusion Criteria: * Pregnancy and female patients of child-bearing potential planning a pregnancy during the study period * Patients with a primary diagnosis of ulcerative colitis or IBD unclassified or microscopic colitis * Patients with disease limited to the upper GI tract, rectum or perianal CD * Patients with a contraindication for MR, colonoscopy and/or ultrasound * Patients with allergy to gadolinium chelated or with eGFR<60 mL/min/1.73m2 * Patients unwilling or unable to provide informed, written consent.
Locations (0)
No sites listed yet. The official record has contact information.
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.