Calculating the Lemann Index Using Intestinal Ultrasound (EXTENT) V1.0
Research type
Research Study
Full title
Calculating the Lemann Index Using Intestinal Ultrasound (EXTENT)
IRAS ID
357250
Contact name
Stuart Taylor
Contact email
Sponsor organisation
International Bowel Ultrasound Group e.V. (IBUS)
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 16 days
Research summary
The EXTENT study has been organised to learn more about how reliable intestinal ultrasound is for assessing bowel damage in the context of Crohn’s disease. Intestinal ultrasound (IUS) is a non-invasive tool increasingly used to assess inflammation in the bowel, which is the lower intestinal tract, and any damage caused to it, like in Crohn's disease (CD). However, there is currently no reliable, validated standard to support the global adoption and use of the IUS in monitoring bowel damage in patients with CD. A bowel damage score has already been developed in a previous study using MR enterography and colonoscopy. This study aims to verify whether intestinal ultrasonography can reliably replace colonoscopy and MR enterography to assess bowel damage in Crohn’s disease.
People can participate if they have been diagnosed with or are suspected to have Crohn’s disease, and have been prescribed tests by his/her doctor that align with the study procedures. This means that the examinations were prescribed in the usual manner, as standard of care, in accordance with the conditions of good medical practice.
Participation in this study involves completing the imaging procedures prescribed as standard of care (intestinal ultrasound, magnetic resonance enterography, and if needed, colonoscopy), questionnaires related to patients' experience with Crohn’s disease, and providing blood and stool samples. Participation in the study may last up to 8 weeks.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
25/SW/0093
Date of REC Opinion
17 Sep 2025
REC opinion
Further Information Favourable Opinion