Purpose of this Study
We are doing this study to find out if an experimental drug called ASP5354 (the study drug) is a safe and effective option that can help surgeons see patients' ureters better during surgeries.
Who Can Participate?
Eligibility
Adults ages 18+ who are scheduled to have an abdominal or pelvic surgery at Duke.
For more information about this study, contact the study team at felecia.walton@duke.edu.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment to either:
- Get a single dose of the study drug during your surgery; OR
- Get a placebo (inactive substance with no drug in it) during your surgery
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
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 Adult Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries
Principal Investigator
Christophe
Mantyh
Protocol Number
PRO00116263
NCT ID
NCT05754333
Phase
III
Enrollment Status
Pending Open to Enrollment