The aim of this study is to evaluate non-invasive imaging techniques for assessing treatment response in known Crohn's disease. 1. Comparing imaging modalities: The applicability of small bowel colon capsule endoscopy (SBCCE), magnetic resonance enterocolonography (MREC) and ultrasound (US) for diagnosing ulcer healing after medical treatment in patients with symptomatic Crohn's disease compared to ileocolonoscopy. 1. Sensitivity and specificity for ulcer healing. 2. Changes in activity parameters for SBCCE, MREC and US before and after medical treatment. 3. Feasibility of SBCCE, MREC and US for assessing treatment response in known Crohn's disease. 2. Treatment induced bowel wall alterations visualized with ultrasound: 1. A non-blinded study of bowel wall changes detected with repeated US examination during medical treatment of known Crohn's disease. 2. Changes in bowel wall thickness, vascularity and elastography parameters, and time to normalization of the bowel wall.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
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. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
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. |
NCT03435016 |
Phase
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. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Sygehus Lillebaelt |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Michael D Jensen, MD, PhD |
Principal Investigator Affiliation | Lillebaelt Hospital Vejle |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | Denmark |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Crohn Disease |
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