跳至主要内容
临床试验/EUCTR2018-000985-12-NL
EUCTR2018-000985-12-NL进行中(未招募)1 期

ear-infrared fluorescence imaging in kidney transplantations using ZW800-1 for perfusion assessment: a pilot study

eiden University Medical Center0 个研究点目标入组 20 人开始时间: 2018年7月3日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

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

入选标准

  • 1) Patients > 18 years old;
  • 2) Patient couples scheduled for a living donor nephrectomy and kidney transplantation;
  • 3) Patients should be capable and willing to give informed consent before study specific procedures;
  • 4) No unacceptable known cardiovascular or pulmonary disease, renal or liver dysfunction;
  • 5) The screening ECG and laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant;
  • 6) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
  • 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 20
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • 1) History of a clinically significant allergy or anaphylaxis;
  • 2) Patients who previously underwent a kidney transplantation;
  • 3) Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
  • 4) Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.

研究者

发起方
eiden University Medical Center

相似试验