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Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery
Sponsor: Curadel Surgical Innovations, Inc.
Summary
The goal of this clinical trial is to determine if the drug Nizaracianine Triflutate can help surgeons see and avoid the ureters during abdominopelvic surgery. The ureters are thin-wall, collapsible tubes that connect the kidneys to the bladder. They are difficult to see during surgery and are sometimes damaged accidentally. The main questions to answer are: 1) is this drug safe for use in patients undergoing abdominopelvic surgery and 2) can the drug see the ureters while simultaneously providing information about how well they are working. The clinical trial has 3 parts. Surgery patients enrolled in the first part (Phase 2) will receive drug at different doses to determine the best dose. Patients enrolled in the second part (Phase 3A) will be randomly assigned to drug or placebo (sugar), at the best dose from Phase 2, so the two can be compared directly. Patients enrolled in the final part (Phase 3B) will all receive drug at the best dose from Phase 2.
Official title: Phase 2/3 Randomized Controlled Semi-blinded Trial to Investigate Safety and Effectiveness in Ureter Visualization With Intravenous Nizaracianine Triflutate, in up to 3 Divided Doses, in Adults Undergoing Abdominopelvic Surgery (TRIPHASE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
336
Start Date
2024-06-28
Completion Date
2026-08
Last Updated
2026-02-23
Healthy Volunteers
No
Interventions
Nizaracianine Triflutate
Participants will receive up to 3 intravenous bolus injections with a minimal interval between doses of 60 minutes (surgeon discretion). Dose will be 1.0 or 2.5 mg depending on trial phase.
Placebo Comparator
In Phase 3A only, \~50 subjects will be randomly allocated to receive sugar placebo
Locations (10)
Cedars Sinai Medical Center
Los Angeles, California, United States
Board of Trustees of Leland Stanford Junior University
Redwood City, California, United States
AdventHealth Orlando
Orlando, Florida, United States
AdventHealth Tampa
Tampa, Florida, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
University Medical Center Groningen
Groningen, Netherlands
Martini Hospital
Groningen, Netherlands
Leiden University Medical Centre (LUMC)
Leiden, Netherlands
Erasmus Medical Centre
Rotterdam, Netherlands
Isala Zwolle
Zwolle, Netherlands