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Clinical trialNCT06101745RecruitingPhase 2/PHASE3Interventional

Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery

SponsorCuradel Surgical Innovations, Inc.Enrollment336Injury of Ureter During Surgery (Disorder)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Netherlands
  • Martini Hospital

    Groningen, Netherlands

    Recruiting
  • University Medical Center Groningen

    Groningen, Netherlands

    Recruiting
  • Leiden University Medical Centre (lumc)

    Leiden, Netherlands

    Recruiting
  • Erasmus Medical Centre

    Rotterdam, Netherlands

    Recruiting
  • Isala Zwolle

    Zwolle, Netherlands

    Recruiting
United States
  • 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

    Mark Soliman, M.D.
    Recruiting
  • Adventhealth Tampa

    Tampa, Florida, United States

    Ahmed Allawi, M.D.
    Recruiting
  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, United States

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Nizaracianine TriflutatePlacebo Comparator
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Jun 2024
Primary completion
31 Jul 2026
Completion
31 Aug 2026
Last update posted
23 Feb 2026
Registered enrollment
336
Registry id
NCT06101745

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.