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临床试验/NCT01074580
NCT01074580终止不适用

High Frequency Ultrasound and Contrast Enhanced Ultrasound of Patients Treated for Deterioration of Crohn's Disease

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
20
试验地点
1
主要终点
Remission defined by Crohns disease activity index (CDAI)<150

研究概览

简要总结

The purpose of this study is investigate if high frequency sonography and contrast enhanced sonography can be used to predict remission in patients with deterioration of Crohn's disease treated with steroids or tumor necrosis factor (TNF) alfa inhibitors.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Deterioration of Crohn's disease
  • CDAI>150
  • Treated with systemic steroids or TNF alfa inhibitors
  • Lesion found on ultrasound

排除标准

  • Disease location not reachable with ileocolonoscopy
  • Pregnancy
  • Acute coronary disease
  • Unstable coronary disease
  • Previous allergic reaction to SonoVue or its components

结局指标

主要结局

Remission defined by Crohns disease activity index (CDAI)<150

时间窗: 52 weeks from inclusion

次要结局

  • Mucosal healing on ileocolonoscopy. Defined by Simple Endoscopic Index for Crohn's disease (SES-CD)(12 weeks)
  • Surgical treatment for Crohn's disease during follow up. (Surgery for perianal disease not included.)(52 weeks)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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