NCT06101745 · Curadel Surgical Innovations, Inc.
Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery
(TRIPHASE)
What this study 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.
View original scientific description
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.
Interventions
DRUG
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.
DRUG
Placebo Comparator
In Phase 3A only, \~50 subjects will be randomly allocated to receive sugar placebo
Primary outcome measures
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)
The proportion of subjects for whom the surgeon is able to successfully identify the required length of the ureters (specified by the surgeon at each timepoint) with a peak signal-to-background ratio (SBR) ≥ 1.5 where SBR is signal-to-background ratio - verified by three independent blinded reviewers
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 pot
Where
- Los Angeles, California
- Redwood City, California
- Orlando, Florida
- Tampa, Florida
- Worcester, Massachusetts
Collaborators
Leiden University Medical Center, Erasmus Medical Center, University of Massachusetts, Worcester, Stanford University, Cedars-Sinai Medical Center, University Medical Center Groningen, Martini Hospital Groningen, Isala, AdventHealth
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 23, 2026 · Source of record for eligibility and locations