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RECRUITING
NCT06101745
PHASE2/PHASE3

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

Sponsor: Curadel Surgical Innovations, Inc.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

336

Start Date

2024-06-28

Completion Date

2026-08

Last Updated

2026-02-23

Healthy Volunteers

No

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

Locations (10)

Cedars Sinai Medical Center

Los Angeles, California, United States

Board of Trustees of Leland Stanford Junior University

Redwood City, California, United States

AdventHealth Orlando

Orlando, Florida, United States

AdventHealth Tampa

Tampa, Florida, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

University Medical Center Groningen

Groningen, Netherlands

Martini Hospital

Groningen, Netherlands

Leiden University Medical Centre (LUMC)

Leiden, Netherlands

Erasmus Medical Centre

Rotterdam, Netherlands

Isala Zwolle

Zwolle, Netherlands