Condition: Injury of Ureter During Surgery (Disorder) · Sponsor: Curadel Surgical Innovations, Inc.
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.
This description comes directly from the study's public registry record.
Alexander L Vahrmeijer, M.D., Ph.D. · +31 71 526 9111 · a.l.vahrmeijer@lumc.nl
Cedric Pesch, M.D. · +31 71 526 9111 · c.m.w.pesch@lumc.nl
Always discuss trial participation with your own doctor first.
| Cedars Sinai Medical Center | Los Angeles, California, United States | Recruiting |
| Board of Trustees of Leland Stanford Junior University | Redwood City, California, United States | Recruiting |
| AdventHealth Orlando | Orlando, Florida, United States | Recruiting |
| AdventHealth Tampa | Tampa, Florida, United States | Recruiting |
| University of Massachusetts Chan Medical School | Worcester, Massachusetts, United States | Recruiting |
| University Medical Center Groningen | Groningen, Netherlands | Recruiting |
| Martini Hospital | Groningen, Netherlands | Recruiting |
| Leiden University Medical Centre (LUMC) | Leiden, Netherlands | Recruiting |
| Erasmus Medical Centre | Rotterdam, Netherlands | Recruiting |
| Isala Zwolle | Zwolle, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06101745