Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery

Recruiting Phase 2 Phase 3 Interventional Study
Injury of Ureter During Surgery (Disorder)
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Prevention
Participants needed
336 (estimated)
Sponsor
Curadel Surgical Innovations, Inc. · Industry
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About This Trial
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 patient…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old * Scheduled to undergo a medically necessary abdominopelvic surgical procedure expected to last ≥ 2 hours (Phase 2) or any duration (Phase 3), during which one or more ureters should be visualized during the procedure. All abdominopelvic surgical procedures …
Contacts

Alexander L Vahrmeijer, M.D., Ph.D.

+31 71 526 9111

a.l.vahrmeijer@lumc.nl

CONTACT

Cedric Pesch, M.D.

+31 71 526 9111

c.m.w.pesch@lumc.nl

CONTACT