The trial is conducted in patients where ZW800-1 is used to visualize ureters during surgery.
Conditions
Interventions
Product Name: ZW800-1
Product Code: ZW800-1
Pharmaceutical Form: Solution for injection
Sponsors
LUMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the feasibility of ZW800-1 in intraoperative detection of the urinary tract using the NIR fluorescence imaging system. ;Secondary Objective: To define the optimal dose of ZW800-1 for intraoperative imaging of the urinary tract. ;Primary end point(s): Efficacy endpoint: Signal-to-background ratio, defined as fluorescence signal in the ureters compared to fluorescence signal of the surrounding tissue, at different doses. Safety and tolerability endpoint: The occurrence or absence of adverse events following administration of ZW800-1 in patients. Pharmacokinetic endpoint: Analysis of blood and urine samples for serum biochemistry, hematology and pharmacokinetics. ;Timepoint(s) of evaluation of this end point: Follow-up: 24 hours post dosing and day of discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Netherlands
Contacts
Public ContactA.L. Vahrmeijer
LUMC
Outcome results
None listed