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New treatment option for Injury of Ureter During Surgery (Disorder)
Official title Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery
ClinicalTrials.gov ID: NCT06101745
What this study is testing
What is Nizaracianine Triflutate?
Nizaracianine Triflutate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for injury of ureter during surgery (disorder).
Also referred to as ZW800-1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Negative pregnancy test in women of childbearing potential Exclusion Criteria:
See the full eligibility 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...
- 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 Exclusion Criteria:
- 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...
- Coagulopathy as manifested by international normalized ration (INR) \> 1.3 (unless patient is on anti-coagulants)
- people 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 people with reproductive potential: for males, condom use; for females, oral contraceptives, diaphragm...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Redwood City, California, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Worcester, Massachusetts, United States
- Groningen, Netherlands
- Leiden, Netherlands
- Rotterdam, Netherlands
- Zwolle, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Redwood City, California, United States; Orlando, Florida, United States; Tampa, Florida, United States; Worcester, Massachusetts, United States; Groningen, Netherlands and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.