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NCT01074580 Clinical Trial

Contrast Enhanced Ultrasonography (CEUS) of Patients With Crohn's Disease

Crohn's Disease Clinical Trial

Official title:
High Frequency Ultrasound and Contrast Enhanced Ultrasound of Patients Treated for Deterioration of Crohn's Disease

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01074580
Other study ID # 22209
Secondary ID
Status Terminated
Phase N/A
First received February 23, 2010
Last updated January 25, 2016
Start date November 2009
Est. completion date December 2013

Study information
Verified date January 2016
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial Summary

The purpose of this study is investigate if high frequency sonography and contrast enhanced sonography can be used to predict remission in patients with deterioration of Crohn's disease treated with steroids or tumor necrosis factor (TNF) alfa inhibitors.

Recruitment information / eligibility
Status Terminated
Enrollment 20
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Deterioration of Crohn's disease

- CDAI>150

- Treated with systemic steroids or TNF alfa inhibitors

- Lesion found on ultrasound

Exclusion Criteria:

- Disease location not reachable with ileocolonoscopy

- Pregnancy

- Acute coronary disease

- Unstable coronary disease

- Previous allergic reaction to SonoVue or its components

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Department of Medicine, Haukeland University Hospital Bergen Hordaland

Sponsors (3)
Lead Sponsor Collaborator
Haukeland University Hospital Abbott, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Remission defined by Crohns disease activity index (CDAI)<150 52 weeks from inclusion No
Secondary Surgical treatment for Crohn's disease during follow up. (Surgery for perianal disease not included.) 52 weeks No
Secondary Mucosal healing on ileocolonoscopy. Defined by Simple Endoscopic Index for Crohn's disease (SES-CD) 12 weeks No
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