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Small Intestinal Mucosal Abnormalities in Systemic Sclerosis Using Capsule Endoscopy (sclero-video)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00958672
First Posted: August 13, 2009
Last Update Posted: June 19, 2014
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.
Information provided by (Responsible Party):
University Hospital, Rouen
July 17, 2009
August 13, 2009
June 19, 2014
August 2009
September 2011   (Final data collection date for primary outcome measure)
Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00958672 on ClinicalTrials.gov Archive Site
  • - to assess a correlation between the presence of small intestinal mucosal abnormalities and digestive symptoms [ Time Frame: 1 year ]
  • to assess a correlation between small intestinal mucosal abnormalities and nutritional status [ Time Frame: 1 year ]
  • to assess a correlatio between small intestinal mucosal abnormalities and extra-intestinal manifestations of systemic sclerosis [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
Small Intestinal Mucosal Abnormalities in Systemic Sclerosis Using Capsule Endoscopy
Evaluation Des Anomalies Muqueuses Intestinales Par vidéocapsule Endoscopique au Cours de la sclérodermie systémique : Etude Prospective, Multicentrique et Inter-régionale
The aim of this prospective study is to determine prevalence and characteristics of small intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule endoscopy. The investigators' findings may improve management of small intestinal involvement in patients with systemic sclerosis.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
40 consecutive patients with systemic sclerosis will be included in this prospective study, without prior selection on digestive clinical manifestations
Systemic Sclerosis
Other: Endoscopic capsule
Endoscopic capsule
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 81 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00958672
2008/074/HP
Yes
Not Provided
Not Provided
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Not Provided
University Hospital, Rouen
June 2014