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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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12 December 2020 |
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Main ID: |
NCT03235180 |
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Date of registration:
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27/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ultrasound Evaluation of Crohn's Disease
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Scientific title:
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Ultrasound Evaluation of Crohn's Disease |
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Date of first enrolment:
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June 16, 2017 |
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Target sample size:
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100 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/show/NCT03235180 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Shigao Chen, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Crohn's disease patients with involvement of terminal ileum (thickness > 3mm).
- Scheduled to start new medical therapy (change of medicine or dosage).
- Clinically indicated contrast enhanced Magnetic Resonance Enterography (MRE) at
baseline and 6 months.
Exclusion Criteria:
- Patients with change of medicine or going to surgery over the 6-months follow-up
period.
- Patients with unreliable ultrasound images due to conditions such as large body
habitus or poor ultrasound imaging window.
- Adults lacking capacity to consent.
- Vulnerable subjects such as prisoners.
- Pregnant women and nursing mothers.
- Patients with known or suspected right-to-left, bi-directional, or transient
right-to-left cardiac shunts.
- Patients with history of hypersensitivity allergic reactions to ultrasound contrast
agents.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Device: Ultrasound Elastography
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Drug: Sulfur Hexafluoride
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Device: Magnetic Resonance Enterography (MRE)
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Device: Ultrasound Vascularity
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Primary Outcome(s)
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Change in vessel density
[Time Frame: baseline, 6 months]
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Change in shear wave speed
[Time Frame: baseline, 6 months]
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Secondary ID(s)
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17-001175
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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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