Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|International Bowel Ultrasound Group e.V.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Kerri Novak, Prof|
|Principal Investigator Affiliation||University of Calgary|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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. Confirmed diagnosis of CD according to standard clinical, endoscopic, and histologic criteria of at least 3 months duration. 2. Adults 18 years of age or older. 3. Moderate to severely active CD defined by: 1. Active symptoms with a HBI ≥ 8, and. 2. Bowel wall inflammation defined as bowel wall thickness (BWT) > 3 mm in at least 1 segment of the ileum or colon as determined by IUS. 4. Patients with planned introduction of biologic therapy as per their treating gastroenterologist to treat active disease. 5. Written informed consent must be obtained and documented. Exclusion Criteria: 1. Patients with a primary diagnosis of ulcerative colitis or IBD type unclassified. 2. Patients with prior intestinal surgery. 3. Patients with disease-related structural bowel complications, defined as either: 1. 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. 2. 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]) 4. Contraindication to IC or MRE. 5. BMI greater than 35 at time of screening or other characteristics considered likely to preclude IUS visualization of all bowel segments. 6. Disease limited to the rectum. 7. 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. 8. 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. 9. Pregnancy Data Sources and Data Collection Data will be collected from patient charts (paper or electronic) including medical and CD related history, medication records, and results of prior laboratory and imaging examinations. Patient disease-related outcomes including hospitalizations, emergency department (ED) visits, and surgeries will be collected during visits for analysis. Data will be transcribed from the patient's chart and entered into an electronic case report form by the investigator or authorized trained designee. Questionnaires are to be completed by healthcare professionals and patients (i.e., baseline demographics, HRQoL ]SIBDQ], PRO-2, IBD Knowledge Questionnaire). Outcomes. Primary Outcome: • The longitudinal and construct validity and treatment responsiveness of an IUS CD activity index in an adult population with moderate to severely active CD. Secondary Outcomes:
: Crohns disease patients
Adult patients with moderately to severely active CD
Diagnostic Test: - Ultrasound, Colonoscopy, MRE
After the initiation of an established treatment of known efficacy for CD (biologic agents including infliximab, adalimumab, ustekinumab or vedolizumab either with or without corticosteroids), repeat IC and MRE will occur at Week 30 (± 6 weeks) (6-9 months); the IUS, IC, and MRE examinations will occur within a 4-week window and with no intervening change in medical therapy. All imaging data will be captured electronically (IUS and MRE with Digital Imaging and Communications in Medicine [DICOM] images, and IC with video recordings) for central, blinded reading. Two biopsies will be collected from each segment of the bowel (rectum, sigmoid, descending, transverse, ascending and terminal ileum) during IC, fixed in formalin collection containers, and shipped for histopathology processing and evaluation.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.