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临床试验/EUCTR2014-003614-87-NO
EUCTR2014-003614-87-NO进行中(未招募)1 期

ovel Imaging of the Eustachian Tube, a CT study using dilute iodixanol in an adult population

Oslo University Hospital0 个研究点目标入组 23 人开始时间: 2015年2月11日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
23

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • -patient > 18 years
  • -reffered to ENT clinic at our hospital for evaluation and treatment of OME, tympanic membrane perforation, or tympanic membrane retraction
  • -dysfunction of the ET is suspected by the ENT surgeon
  • -the patient is a candidate for Balloon dilation of the ET
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 65
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -previous serious allergic reaction to iodine based contrast medium
  • -increased risk of bleeding
  • -serious heart disease
  • -diabetes I
  • -previous ENT-surgery (t-tubes excluded)
  • -middle ear disease, which requires other type of treatment
  • -chronic rhino sinusitis or nasal polyposis
  • -anatomical variations in the temporal bone or scull base that contraindicates balloon dilation
  • -females who are pregnant or breast feeding

研究者

发起方
Oslo University Hospital

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