Visualizing Ureters During Abdominopelvic Surgery with Nizaracianine Triflutate
Phase 2/3 Randomized Controlled Semi-blinded Trial to Investigate Safety and Effectiveness in Ureter Visualization With Intravenous Nizaracianine Triflutate, in up to 3 Divided Doses, in Adults Undergoing Abdominopelvic Surgery (TRIPHASE)
This study is testing a new drug to see if it can help doctors see ureters better during surgery to prevent injuries.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Curadel Surgical Innovations, Inc. Industry-sponsored |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT06101745 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of Nizaracianine Triflutate in enhancing the visibility of ureters during abdominopelvic surgery. The study is divided into three phases: the first phase will determine the optimal dosage of the drug, while the second phase will compare the drug's effectiveness against a placebo in a randomized manner. The final phase will administer the best dose of the drug to all participants to assess its utility in real-time ureter visualization. The goal is to reduce the incidence of ureter injuries, which can lead to significant complications and healthcare costs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for medically necessary abdominopelvic surgery lasting at least two hours where ureter visualization is required.
Not a fit: Patients undergoing surgical procedures where ureter visualization is not necessary or those with contraindications to the drug will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of ureter injuries during surgery, leading to better patient outcomes and lower healthcare costs.
How similar studies have performed: While the specific use of Nizaracianine Triflutate is novel, similar studies focusing on enhancing surgical visualization have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Los Angeles, California and 9 other locations
- 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)
Study contacts
- Principal investigator: Alexander L Vahrmeijer, M.D., Ph.D — Leiden University Medical Centre (LUMC)
- Study coordinator: Alexander L Vahrmeijer, M.D., Ph.D.
- Email: a.l.vahrmeijer@lumc.nl
- Phone: +31 71 526 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.