ASP5354: A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 with Near-infrared Fluorescence (NIR-F) Imaging in Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries.

Study Purpose: The biological father of your child is/was participating in a research study of an Investigational or experimental medicine that has not received approval from governmental regulatory authorities such as the U.S. FDA (United States Food and Drug Administration) for use in your country of residence.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if
you meet the following criteria:

Study Duration: 14 days

Study Commitment:
Initial Screening visit
Intra-operative visit
Follow up visit

Age: Over 18 years old

Sex: Male & Female

Conditions/Eligibility:

inclusion:
1. Participant is ≥ 12 years of age at the time of signing an ICF.
2.Participant is scheduled to undergo minimally invasive or open abdominopelvic surgery that may require ureter identification.
3. Participant has normal renal function or has varying degrees of chronic kidney disease as defined by the National Kidney Foundation and calculated by individual eGFR using the modification of diet in renal disease (MDRD) formula for adults or the Schwartz formula for adolescents at the screening visit.
● Adult normal/mild eGFR
● Adult moderate/severe eGFR
● Adolescent
4. Female participant is not pregnant and at least 1 of the following conditions apply
a. Not a woman of childbearing potential (WOCBP
b. WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after study intervention administration.
Exclusion
1. Participant has had previous exposure to ASP5354.
2.Participant has been administered ICG or other NIR-F imaging agents within 48 hours prior to ASP5354 administration, with the exception of participants who receive ICG for lymphatic mapping before the surgery.
3.Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to randomization.
4. Participant is on hemodialysis, hemodiafiltration or peritoneal dialysis

Study Procedures:
As a recommendation, the following order should be followed when more than 1 assessment is required at a scheduled time point.
1. Vital signs
2. ECG/cardiac monitoring
3. Blood collection

Compensation: None