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NCT00958672 Clinical Trial

Small Intestinal Mucosal Abnormalities in Systemic Sclerosis Using Capsule Endoscopy

Systemic Sclerosis Clinical Trial

— sclero-video  

Official title:
Evaluation Des Anomalies Muqueuses Intestinales Par vidéocapsule Endoscopique au Cours de la sclérodermie systémique : Etude Prospective, Multicentrique et Inter-régionale

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00958672
Other study ID # 2008/074/HP
Secondary ID
Status Completed
Phase N/A
First received July 17, 2009
Last updated June 18, 2014
Start date August 2009
Est. completion date September 2011

Study information
Verified date June 2014
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 81 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Endoscopic capsule
Endoscopic capsule

Locations
Country Name City State
France CHU-Rouen Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis 1 year No
Secondary - to assess a correlation between the presence of small intestinal mucosal abnormalities and digestive symptoms 1 year No
Secondary to assess a correlation between small intestinal mucosal abnormalities and nutritional status 1 year No
Secondary to assess a correlatio between small intestinal mucosal abnormalities and extra-intestinal manifestations of systemic sclerosis 1 year No
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