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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 June 2015 |
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Main ID: |
NCT02061163 |
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Date of registration:
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06/02/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Contrast-Enhanced Ultrasound in Human Crohn's Disease
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Scientific title:
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Evaluation of Contrast-Enhanced Ultrasound in Human Crohn's Disease |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT02061163 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients 10 years of age and older
- Have been diagnosed with small bowel Crohn's disease
- Are receiving medical therapy for Crohn's disease
- Are scheduled for surgery (bowel resection) OR
- Are scheduled for a clinically-indicated MR enterography (MRE)/MRI exam.
Exclusion Criteria:
- Patients under the age of 10
- Are pregnant or breast feeding
- Are significantly overweight - BMI >35-40
- Have an inability to understand the consent
- Have prior allergic-like reaction or other adverse reaction to microbubble contrast
agent
- Hypersensitivity to perflutren, blood, blood products or albumen
- Have a cardiac shunt
- Known unstable cardiac condition such as history of a heart attach, irregular
heartbeat, congestive heart failure, etc.
- Known acute or chronic kidney disease, moderate/severe lung disease or acute or
chronic liver disease
Age minimum:
10 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Device: Contrast Enhanced Ultrasound
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Drug: Optison
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Primary Outcome(s)
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Evaluation of bowel wall inflammation and fibrosis in patients with Crohn's disease using CEUS
[Time Frame: 2 years]
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Secondary ID(s)
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HUM00080030
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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