Small Intestinal Mucosal Abnormalities in Systemic Sclerosis Using Capsule Endoscopy

NCT ID: NCT00958672

Last Updated: 2014-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Endoscopic capsule

Endoscopic capsule

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU-Rouen

Rouen, Rouen, France

Site Status

Countries

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France

Other Identifiers

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2008/074/HP

Identifier Type: -

Identifier Source: org_study_id

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