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New dye could help surgeons avoid a common, dangerous mistake

NCT ID NCT06101745

Diagnosis Sponsor: Curadel Surgical Innovations, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called Nizaracianine Triflutate that makes the ureters (tubes from kidneys to bladder) glow during surgery, so surgeons can see and avoid them. About 336 adults having abdominal or pelvic surgery will receive the drug or a placebo. The goal is to see if the drug is safe and helps prevent accidental ureter injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 336 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Injury of ureter during surgery (disorder)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • AdventHealth Tampa

    RECRUITING

    Tampa, Florida, 33613, United States

  • Board of Trustees of Leland Stanford Junior University

    RECRUITING

    Redwood City, California, 94063, United States

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Erasmus Medical Centre

    RECRUITING

    Rotterdam, 3015 GD Rotterdam, Netherlands

  • Isala Zwolle

    RECRUITING

    Zwolle, 8000 GK Zwolle, Netherlands

    Contact Email: •••••@•••••

  • Leiden University Medical Centre (LUMC)

    RECRUITING

    Leiden, 2333 ZA Leiden, Netherlands

  • Martini Hospital

    RECRUITING

    Groningen, 9728 NT Groningen, Netherlands

    Contact Email: •••••@•••••

  • University Medical Center Groningen

    RECRUITING

    Groningen, 9713 GZ Groningen, Netherlands

    Contact Email: •••••@•••••

  • University of Massachusetts Chan Medical School

    RECRUITING

    Worcester, Massachusetts, 01655, United States