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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 procedures
MedDRA version: 14.1Level: PTClassification code 10059696Term: Scan with contrastSystem Organ Class: 10022891 - Investigations
MedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1Level: LLTClassification code 10028049Term: MRISystem Organ Class: 10022891 - Investigations
MedDRA version: 14.1Level: PTClassification code 10045434Term: Ultrasound scanSystem Organ Class: 10022891 - Investigations
MedDRA version: 14.1Level: PTClassification code 10022699Term: Intestinal stenosisSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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