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Studies

Observational Not yet recruiting

NCT06647823 on ClinicalTrials.gov

Calculating the LEmann IndeX Using InTEstiNal Ultrasound

  • Sponsor: UL (Group)
  • Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
  • Enrollment: 102 (Estimated)
  • Study start: 2024-12-01 (Estimated)
  • Primary completion: 2025-12-01 (Estimated)
  • Study completion: 2026-06-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

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. With this study the investigators aim to show that IUS can replace Magnetic Resonance Enterography (MRE), which has been used to develop the original Lèmann-Index, to evaluate structural bowel damage.

For each patient, IUS and MRE (and Colonoscopy, if the colon is involved) will be performed within a two-month timeframe.

Conditions

  • Crohn Disease (CD)

Primary Outcome Measures

  • Intraclass correlation between the LI-IUS scores and the LI-MRE scores assessing small bowel damage and colon damage in patients with CD. (Baseline)