Lower abdominal and pelvic laparoscopic surgeries
Conditions
Interventions
Injection ZW800-1 and fluorescence imaging during surgery
Sponsors
Leiden University Medical Center, Leiden, the Netherlands
Eligibility
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;
Exclusion criteria
Exclusion criteria: Patients will be excluded if any of the criteria below apply: 1) History of a clinically significant allergy or anaphylaxis; 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 |
|---|---|
| To assess the feasibility of ZW800-1 in intraoperative detection of the urinary tract using the NIR fluorescence imaging system. | — |
Secondary
| Measure | Time frame |
|---|---|
| To define the optimal dose of ZW800-1 for intraoperative imaging of the urinary tract. | — |
Contacts
Public ContactA.L. Vahrmeijer
Box 9600
Outcome results
None listed