Recruiting
Phase 2
Phase 3

Nizaracianine Triflutate

Sponsor:

Curadel Surgical Innovations, Inc.

Code:

NCT06101745

Conditions

Injury of Ureter During Surgery (Disorder)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nizaracianine Triflutate

Placebo Comparator

Study Details

Brief 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.

Conditions

Injury of Ureter During Surgery (Disorder)

Study ID

NCT06101745

Start date

Jun 28, 2024

Status verified date

Feb, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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

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 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.

Study Design

Enrollment

336 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Nizaracianine Triflutate Study Drug Arm

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: Sugar Comparator Arm

In Phase 3A only, \~50 subjects will be randomly allocated to receive sugar placebo.

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

Primary outcome measure

  • The fraction of subjects for whom the surgeon is able to successfully identify the required length of the ureters (specified by the surgeon at each timepoint), as verified by three independent blinded reviewers. [ Time Frame: 1 day (day of surgery) ]

Central Contacts and Locations

Central contacts

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

+31 71 526 9111a.l.vahrmeijer@lumc.nl

Cedric Pesch, M.D.

+31 71 526 9111c.m.w.pesch@lumc.nl

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Clinical Research Coordinator or Clinical Research Specialist

310-423-0201michael.fernandez2@cshs.org; amy.hoang@cshs.org

Board of Trustees of Leland Stanford Junior University

Recruiting

Redwood City, California, United States, 94063

Contacts

Gynecology Research Team

650-497-5175gynresearch@stanford.edu

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Candy Cabrera

407-303-5503candy.cabrera@adventhealth.com

Rosemary Vargas

Rosemary.Vargas@AdventHealth.com

Principal Investigator:

Mark Soliman, M.D.

AdventHealth Tampa

Recruiting

Tampa, Florida, United States, 33613

Contacts

Daniel Robledo

813-610-8110Daniel.Robledo@adventhealth.com

Gerardo Bustos

Gerardo.Bustos@AdventHealth.com

Principal Investigator:

Ahmed Allawi, M.D.

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Clinical Research Coordinator

603-362-2406Samantha.Cocchiaro@umassmemorial.org

Clinical Coordinator

508-334-8195katelyn.stickney@umassmemorial.org

More Information

Sponsor

Curadel Surgical Innovations, Inc.

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • Nizaracianine Triflutate
  • ZW800-1
  • ureter
  • ureter visualization
  • abdominopelvic surgery
  • Near-infrared
  • fluorescence imaging
  • TRIPHASE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Curadel Surgical Innovations, Inc. on 2026-02-23.