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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: |
NCT00958672 |
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Date of registration:
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17/07/2009 |
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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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Small Intestinal Mucosal Abnormalities in Systemic Sclerosis Using Capsule Endoscopy
sclero-video |
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Scientific title:
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Evaluation Des Anomalies Muqueuses Intestinales Par vidéocapsule Endoscopique au Cours de la sclérodermie systémique : Etude Prospective, Multicentrique et Inter-régionale |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00958672 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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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:
- Written informed consent
- Systemic sclerosis based on the ACR diagnostic criteria
Exclusion Criteria:
- Patients with other connective tissue diseases
- Pregnancy
- Absence of contraception in women
- Patients with pace maker
- Patients with intestinal pseudo-obstruction
Age minimum:
18 Years
Age maximum:
81 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Sclerosis
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Intervention(s)
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Other: Endoscopic capsule
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Primary Outcome(s)
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Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis
[Time Frame: 1 year]
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Secondary Outcome(s)
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to assess a correlatio between small intestinal mucosal abnormalities and extra-intestinal manifestations of systemic sclerosis
[Time Frame: 1 year]
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- to assess a correlation between the presence of small intestinal mucosal abnormalities and digestive symptoms
[Time Frame: 1 year]
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to assess a correlation between small intestinal mucosal abnormalities and nutritional status
[Time Frame: 1 year]
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Secondary ID(s)
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2008/074/HP
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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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