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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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19 February 2015 |
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Main ID: |
NCT01335828 |
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Date of registration:
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10/11/2010 |
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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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Elastography Interest in the Management of Thyroid Nodules
SWETHY |
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Scientific title:
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"ShearWave" Elastography Interest in the Management of Thyroid Nodules |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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125 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01335828 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient aged over 18 years old
- Patient affiliated to social security or similarly regime
- Patients referred for fine needle aspiration or surgery with one or more thyroid
nodules
Exclusion Criteria:
- Patients with too much thyroid nodules or topography too imprecise to allow
unambiguous correlation between echo/elastography data and histology/cytology data
- Patients withan echography/elastography indications cons
- Pregnant women and lactating mothers
- Adult unable to express their consent
- Ward of court or under guardianship
- Person under legal protection
- Person deprived of freedom by judicial or administrative decision
- Person hospitalized without their consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Thyroid Nodules
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Intervention(s)
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Device: Medical ultrasound device (ShearWave system)
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Primary Outcome(s)
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Defined echo/elastography benignity criteria
[Time Frame: two and half years]
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Secondary Outcome(s)
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Assessing the use of elastography in clinical practice
[Time Frame: two and half years]
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Evaluate the diagnostic performance of elastography ShearWave for characterization of thyroid nodules in a population of patients referred for needle biopsy or surgery nodule thyroid
[Time Frame: two and half years]
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Secondary ID(s)
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DCIC 10 24
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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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