Bloodflow measurements in stenotic inflammatory bowel disease.
Phase 1
- Conditions
- Crohns Disease undergoing elective surgery for intestinal stenosis.MedDRA version: 14.1Level: PTClassification code 10058829Term: Elective surgerySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: PTClassification code 10059696Term: Scan with contrastSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 14.1Level: LLTClassification code 10028049Term: MRISystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.1Level: PTClassification code 10045434Term: Ultrasound scanSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.1Level: PTClassification code 10022699Term: Intestinal stenosisSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2011-005846-36-DK
- Lead Sponsor
- Gastroenterology MIDT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Crohns Disease
Referred to elective surgery for intestinal stenosis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
Exclusion Criteria
Female subjects who are pregnant ore breastfeeding.
Contraindications for MRI with Dotarem
Contraindications for Sonovue
Discontinued surgery
Stenosis not detectable by MRI and US.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method