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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00958672
First received: July 17, 2009
Last updated: June 18, 2014
Last verified: June 2014
  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:


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 ]

Enrollment: 50
Study Start Date: August 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
CHU-Rouen
Rouen, France, 76031
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: June 18, 2014
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 July 22, 2014