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

This study is currently recruiting participants.
Verified December 2012 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00958672
First received: July 17, 2009
Last updated: December 21, 2012
Last verified: December 2012

July 17, 2009
December 21, 2012
August 2009
December 2012   (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • to assess a correlation between small intestinal mucosal abnormalities and nutritional status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • to assess a correlatio between small intestinal mucosal abnormalities and extra-intestinal manifestations of systemic sclerosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
 
Recruiting
40
Not Provided
December 2012   (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
Both
18 Years to 81 Years
No
Contact: MARIE Isabelle, Prof (33) 2 32 88 90 03 isabelle.marie@chu-rouen.fr
France
 
NCT00958672
2008/074/HP
Yes
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Not Provided
University Hospital, Rouen
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP