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

NCT ID: NCT01074580

Last Updated: 2016-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Deterioration, Crohn's disease

Patients \> 18 years old with a deterioration of Crohn's disease defined by CDAI \>150 and requiring treatment with systemic steroids or TNF alfa inhibitors

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bergen

OTHER

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Trygve Hausken, PhD

Role: STUDY_DIRECTOR

Nastional Center of Gastroenterological Ultrasonography, Haukeland University Hospital, Bergen, Norway

Locations

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Department of Medicine, Haukeland University Hospital

Bergen, Hordaland, Norway

Site Status

Countries

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Norway

Other Identifiers

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22209

Identifier Type: -

Identifier Source: org_study_id

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