Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.
Intraoperative Ureter Visualization using ASP5354 with NIR-F Imaging (Abdominal and Pelvic Surgery) - Clinical Trial
What is the 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.
What is the Condition Being Studied?
Abdominal/Pelvic Surgery
Who Can Participate in the Study?
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 Group
Adults
What is Involved?
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
You will have a 5-in-6 chance of getting the study drug and a 1-in-6 chance of getting the placebo.
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
Colorectal Surgeon
Protocol Number
IRB:
PRO00116263
NCT:
NCT05754333
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon