Status:
UNKNOWN
Validation of an IUS Activity Index
Lead Sponsor:
International Bowel Ultrasound Group e.V.
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to prospectively validate a novel intestinal ultrasound (IUS) Crohn's disease (CD) activity index and component items, correlating CD activity and responsiveness...
Detailed Description
Study Design Prospective multicenter study of 111 participants with CD with 50 weeks of follow-up Study Population Adult patients with moderately to severely active CD Inclusion Criteria: 1. Confirm...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of CD according to standard clinical, endoscopic, and histologic criteria of at least 3 months duration
- Adults 18 years of age or older
- Moderate to severely active CD defined by:
- Active symptoms with a HBI ≥ 8, and
- Bowel wall inflammation defined as BWT \> 3 mm in at least 1 segment of the ileum or colon as determined by IUS
- Patients with planned introduction of biologic therapy as per their treating gastroenterologist to treat active disease
- Written informed consent must be obtained and documented.
Exclusion
- Patients with a primary diagnosis of ulcerative colitis or IBD type unclassified
- Patients with prior intestinal surgery
- Patients with disease-related structural bowel complications defined as either:
- Stricture with increased bowel wall thickening (\>25% of normal), decreased luminal diameter (\>50% relative to the normal adjacent bowel loop) and proximal dilation (on any imaging modality) or;
- Penetrating complications (excluding perianal fistulizing disease; patients with perianal disease are eligible if there is additional inflammation in another bowel segment \[other than the rectum\]).
- Contraindication to IC or MRE
- BMI greater than 35 at time of screening or other characteristics considered likely to preclude IUS visualization of all bowel segments
- Disease limited to the rectum
- Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study
- History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures
- Pregnancy
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05407350
Start Date
June 1 2022
End Date
June 1 2025
Last Update
June 7 2022
Active Locations (1)
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1
IBUS office
Berlin, Germany, 12161