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

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.

Conditions

• Injury of Ureter During Surgery (Disorder)

Interventions

DRUG

Placebo Comparator

In Phase 3A only, \~50 subjects will be randomly allocated to receive sugar placebo

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.

Sponsors & Collaborators

• Leiden University Medical Center

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• University of Massachusetts Chan Medical School, Worcester

  collaborator UNKNOWN

• Stanford University

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Martini Hospital Groningen

  collaborator OTHER

• Isala

  collaborator OTHER

• AdventHealth

  collaborator OTHER

• Curadel Surgical Innovations, Inc.

  lead INDUSTRY

Principal Investigators

• John V Frangioni, M.D., Ph.D. · Curadel Surgical Innovations, Inc. (CSI)

• John V Frangioni, M.D., Ph.D. · Curadel Surgical Innovations, Inc. (CSI)

• Alexander L Vahrmeijer, M.D., Ph.D · Leiden University Medical Centre (LUMC)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-28

Primary Completion

2026-07-31

Completion

2026-08-31

FDA Drug

Yes

Countries

• United States
• Netherlands

Study Locations