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临床试验/EUCTR2020-000993-27-FR
EUCTR2020-000993-27-FR进行中(未招募)1 期

AGATA: Value of contrast-enhanced ultrasound in adnexal torsion - AGATA

CHRU NANCY0 个研究点目标入组 30 人开始时间: 2020年5月25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
CHRU NANCY
入组人数
30

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
Female

入选标准

  • Age = 18 years
  • Planned surgery for suspected adnexal torsion
  • Being affiliated to the Social Security system or benefiting from such a system
  • Have received full information about the organization of the study and have signed their informed consent
  • 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 15
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 15

排除标准

  • Any medical condition that contraindicates the administration of SonoVue® , in particular :
  • o Documented hypersensitivity to sulfur hexafluoride or any of the other components of SonoVue
  • o Woman with acute coronary syndrome or unstable ischemic heart disease
  • o Woman with acute endocarditis
  • o Woman with prosthetic valves
  • o Woman with acute systemic inflammatory disease and/or sepsis
  • o Woman in a state of hypercoagulation and/or recent thromboembolic event
  • o Woman with end-stage kidney or liver disease
  • o Woman with right-left shunt, severe pulmonary arterial hypertension (pulmonary arterial pressure > 90 mmHg)
  • o Woman with uncontrolled systemic hypertension
  • o Woman with respiratory distress syndrome
  • Persons referred in Articles L. 1121-5, L. 1121-7 and L1121-8 of French Public Health Code :
  • o Pregnant woman, parturient or breastfeeding mother
  • o Minor person (not emancipated)
  • o Adult person under legal protection (guardianship, curatorship, legal safeguard)
  • o Adult who is unable to give consent
  • Persons who are deprived of their liberty by a judicial or administrative decision, persons under psychiatric care pursuant to articles L. 3212-1 and L. 3213-1

研究者

发起方
CHRU NANCY

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