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OpenTrials
Completed

NCT Number: NCT00958672

Small Intestinal Mucosal Abnormalities in Systemic Sclerosis Using Capsule Endoscopy

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.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–81 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU-Rouen

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic capsule

Other

Endoscopic capsule

Primary outcomes

  1. Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis

    Time frame: 1 year

Secondary outcomes

  1. - to assess a correlation between the presence of small intestinal mucosal abnormalities and digestive symptoms

    Time frame: 1 year

  2. to assess a correlation between small intestinal mucosal abnormalities and nutritional status

    Time frame: 1 year

  3. to assess a correlatio between small intestinal mucosal abnormalities and extra-intestinal manifestations of systemic sclerosis

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: sclero-video

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 13, 2009
Registry last updated
Jun 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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