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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
History of Changes
  Purpose

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.


Condition Intervention
Systemic Sclerosis
 Other: Endoscopic capsule

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation Des Anomalies Muqueuses Intestinales Par vidéocapsule Endoscopique au Cours de la sclérodermie systémique : Etude Prospective, Multicentrique et Inter-régionale

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - 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 ]

Estimated Enrollment: 40
Study Start Date: August 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Endoscopic capsule
    Endoscopic capsule
  Eligibility

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

40 consecutive patients with systemic sclerosis will be included in this prospective study, without prior selection on digestive clinical manifestations

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958672

Contacts
Contact: MARIE Isabelle, Prof (33) 2 32 88 90 03 isabelle.marie@chu-rouen.fr

Locations
France
CHU-Rouen Recruiting
Rouen, France, 76031
Contact: Isabelle MARIE, Prof     (33) 2 32 88 90 03     isabelle.marie@chu-rouen.fr    
Contact: Isabelle Marie, Prof     (33) 2 32 88 90 03     isabelle.marie@chu-rouen.fr    
Principal Investigator: Isabelle MARIE, Prof            
Sponsors and Collaborators
University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00958672     History of Changes
Other Study ID Numbers: 2008/074/HP
Study First Received: July 17, 2009
Last Updated: December 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
 Connective Tissue Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013