Nizaracianine Triflutate for Ureteral Injury

(TRIPHASE Trial)

Recruiting at 4 trial locations

Overseen By Cedric Pesch, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Curadel Surgical Innovations, Inc.

Must not be taking: 800 nm NIR fluorophores

Disqualifiers: Cardiovascular, Pulmonary, Renal, Liver, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

336 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on an 800 nm NIR fluorophore that is not Nizaracianine, you cannot use it immediately before, during, or after the surgery.

What is the purpose of this trial?

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.

Research Team

Alexander L Vahrmeijer, M.D., Ph.D

Principal Investigator

Leiden University Medical Centre (LUMC)

Katherine T Scott, Ph.D.

Principal Investigator

Curadel Surgical Innovations, Inc. (CSI)

John V Frangioni, M.D., Ph.D.

Principal Investigator

Curadel Surgical Innovations, Inc. (CSI)

Eligibility Criteria

Adults aged 18 or older who are scheduled for abdominopelvic surgery, where the ureters need to be seen, can join this trial. The surgery should last at least 2 hours in Phase 2 and any duration in Phase 3.

Inclusion Criteria

I am scheduled for a surgery in my abdomen or pelvis area that will last 2 hours or more and involves seeing one or more ureters.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 2 Treatment

Participants receive 3 different doses of Nizaracianine Triflutate to determine the best dose for ureter visualization during surgery

1 day (day of surgery)

1 visit (in-person)

Phase 3A Treatment

Participants are randomized to receive either the best dose of Nizaracianine Triflutate or placebo to compare effectiveness

1 day (day of surgery)

1 visit (in-person)

Phase 3B Treatment

All participants receive the best dose of Nizaracianine Triflutate for ureter visualization, with up to three administrations during surgery

1 day (day of surgery)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nizaracianine Triflutate

Trial Overview The trial is testing Nizaracianine Triflutate's ability to help surgeons see the ureters during surgery to prevent injury. It involves three parts: finding the best dose (Phase 2), comparing it with a placebo (Phase 3A), and then using that dose on all patients (Phase 3B).

Participant Groups

Group I: Nizaracianine Triflutate Study Drug Arm Active Control 1 Intervention

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.

Group II: Sugar Comparator Arm Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Curadel Surgical Innovations, Inc.

Lead Sponsor

Trials

1

Recruited

340+

Erasmus Medical Center

Collaborator

Trials

742

Recruited

2,156,000+

University of Massachusetts Chan Medical School, Worcester

Collaborator

Trials

3

Recruited

850+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

Leiden University Medical Center

Collaborator

Trials

580

Recruited

623,000+