NCT00958672已完成不适用
Evaluation Des Anomalies Muqueuses Intestinales Par vidéocapsule Endoscopique au Cours de la sclérodermie systémique : Etude Prospective, Multicentrique et Inter-régionale
University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Systemic sclerosis based on the ACR diagnostic criteria
排除标准
- •Patients with other connective tissue diseases
- •Pregnancy
- •Absence of contraception in women
- •Patients with pace maker
- •Patients with intestinal pseudo-obstruction
结局指标
主要结局
Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis
时间窗: 1 year
次要结局
- - to assess a correlation between the presence of small intestinal mucosal abnormalities and digestive symptoms(1 year)
- to assess a correlation between small intestinal mucosal abnormalities and nutritional status(1 year)
- to assess a correlatio between small intestinal mucosal abnormalities and extra-intestinal manifestations of systemic sclerosis(1 year)
研究者
研究点 (1)
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