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

This study has been terminated.
(Did not get enough patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01074580
First Posted: February 24, 2010
Last Update Posted: January 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Bergen
Abbott
Information provided by (Responsible Party):
Haukeland University Hospital
  Purpose
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.

Condition
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Frequency Ultrasound and Contrast Enhanced Ultrasound of Patients Treated for Deterioration of Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Remission defined by Crohns disease activity index (CDAI)<150 [ Time Frame: 52 weeks from inclusion ]

Secondary Outcome Measures:
  • Surgical treatment for Crohn's disease during follow up. (Surgery for perianal disease not included.) [ Time Frame: 52 weeks ]
  • Mucosal healing on ileocolonoscopy. Defined by Simple Endoscopic Index for Crohn's disease (SES-CD) [ Time Frame: 12 weeks ]

Biospecimen Retention:   Samples With DNA
Mucosal biopsies from the colon and terminal ileum.

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated for deterioration of Crohn's disease either in the out patient clinic or the medical ward of Haukeland University Hospital.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074580


Locations
Norway
Department of Medicine, Haukeland University Hospital
Bergen, Hordaland, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Abbott
Investigators
Study Director: Trygve Hausken, PhD Nastional Center of Gastroenterological Ultrasonography, Haukeland University Hospital, Bergen, Norway
  More Information

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01074580     History of Changes
Other Study ID Numbers: 22209
First Submitted: February 23, 2010
First Posted: February 24, 2010
Last Update Posted: January 26, 2016
Last Verified: January 2016

Keywords provided by Haukeland University Hospital:
Crohn's disease
sonography
contrast enhanced ultrasound

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases