ear-infrared Fluorescence-Enhanced Identification of the Ureters using ZW800-1

MC0 个研究点目标入组 12 人开始时间: 2017年8月3日最近更新: 2020年6月29日

适应症

试验速览

暂无简介。

•1)Patients >18 years old;
•2)Patients scheduled and eligible for laparoscopic surgery in the lower abdominal or pelvic area;
•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 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

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

发起方