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
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