Preventing iatrogenic ureteral damage
Conditions
Interventions
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1) Patients 18 years or older;;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.
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
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoint: Signal-to-background ratio, defined as fluorescence signal in the ureters compared to fluorescence signal of the surrounding tissue, at different doses. | — |
Countries
The Netherlands
Outcome results
None listed