Actively Recruiting
Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery
Led by Curadel Surgical Innovations, Inc. · Updated on 2026-02-23
336
Participants Needed
10
Research Sites
109 weeks
Total Duration
On this page
Sponsors
C
Curadel Surgical Innovations, Inc.
Lead Sponsor
L
Leiden University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 are eligible unless specifically excluded in the Exclusion Criteria.
- For Phase 2, the procedure must require identification of one or both ureters using dissection, mobilization, or other surgical means.
- The planned surgical procedure is open or minimally invasive surgery (MIS), including robotic.
- Both ureters are expected to be present and functional.
- Capable and willing to provide informed consent prior to study-specific procedures
- Screening laboratory test results are within normal limits, or if any are outside of normal limits, they are considered by the site PI, and confirmed by the lead PI, to be clinically insignificant.
- Negative pregnancy test in women of childbearing potential
You will not qualify if you...
- Known cardiovascular or pulmonary disease, renal or liver dysfunction, immunological disease, diabetes, or active cancer that would render the study subject unfit for surgery
- The planned surgical procedure is renal transplant or nephrectomy [note: partial nephrectomy is permitted provided that estimated glomerular filtration rate (eGFR) is not expected to fall below normal age-based limits]
- Prior renal transplant
- Impaired renal function defined as an estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2
- Impaired liver function defined as values > 1.5 times the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin, or < lower limit of normal (LLN) for albumin
- Coagulopathy as manifested by international normalized ration (INR) > 1.3 (unless patient is on anti-coagulants)
- Subjects with a marked baseline prolongation of QT/ corrected QT interval (QTc) interval (e.g., a QTc interval > 480 msec [CTCAE grade 1] using Fridericia's QT correction factor (14)
- History of a clinically significant allergy or anaphylaxis to a component of the investigational medicinal product (IMP)
- Known sensitivity to fluorescent light
- Alcohol or recreational drug use that meets diagnostic and statistical manual of mental disorders (DSM5) criteria for moderate or severe substance use disorder
- Pregnant or breastfeeding, or lack of effective contraception for at least one week post-surgery in male or female subjects with reproductive potential: for males, condom use; for females, oral contraceptives, diaphragm, or intrauterine devices (IUDs)
- Any condition that the investigator considers to be potentially jeopardizing to the study subject's well-being or the study's objectives.
- Participated in an interventional clinical research study within the previous 30 days.
- The planned use of an 800 nm NIR fluorophore that is not Nizaracianine (e.g., indocyanine green or Pafolacianine) immediately before, during, or immediately after the planned abdominopelvic procedure.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Board of Trustees of Leland Stanford Junior University
Redwood City, California, United States, 94063
Actively Recruiting
3
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
4
AdventHealth Tampa
Tampa, Florida, United States, 33613
Actively Recruiting
5
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
6
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ Groningen
Actively Recruiting
7
Martini Hospital
Groningen, Netherlands, 9728 NT Groningen
Actively Recruiting
8
Leiden University Medical Centre (LUMC)
Leiden, Netherlands, 2333 ZA Leiden
Actively Recruiting
9
Erasmus Medical Centre
Rotterdam, Netherlands, 3015 GD Rotterdam
Actively Recruiting
10
Isala Zwolle
Zwolle, Netherlands, 8000 GK Zwolle
Actively Recruiting
Research Team
A
Alexander L Vahrmeijer, M.D., Ph.D.
CONTACT
C
Cedric Pesch, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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