Intraoperative Ureter Visualization using ASP5354 with NIR-F Imaging (Abdominal and Pelvic Surgery)

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
You will have a 5-in-6 chance of getting the study drug and a 1-in-6 chance of getting the placebo.

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
ClinicalTrials.gov