We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  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 ]

Secondary Outcome Measures:
  • - 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958672


Locations
France
CHU-Rouen
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
  More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00958672     History of Changes
Other Study ID Numbers: 2008/074/HP
First Submitted: July 17, 2009
First Posted: August 13, 2009
Last Update Posted: June 19, 2014
Last Verified: June 2014

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