Nizaracianine Triflutate for Ureteral Injury

(TRIPHASE Trial)

Recruiting at 7 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, Nizaracianine Triflutate, to help surgeons avoid damaging the ureters—the tubes connecting the kidneys to the bladder—during abdominal surgeries. The trial aims to determine if the drug is safe and effective in making the ureters visible and assessing their function. It consists of three parts: finding the best dose, comparing the drug to a placebo (a sugar pill), and administering the best dose to all participants. Individuals scheduled for abdominal surgery lasting at least two hours, where ureter visibility is necessary, may qualify. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking medical advancement.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Nizaracianine Triflutate was tested in at least one previous human trial. In these studies, participants generally tolerated the drug well, with most not experiencing serious side effects. No major safety issues were reported, suggesting the treatment is relatively safe for humans. However, more data from ongoing trials is needed to confirm this. The current trial is in advanced stages, indicating some confidence in its safety based on earlier studies. Prospective participants may find this information reassuring regarding the drug's safety so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care for ureteral injury, which typically involves surgical repair and stenting, Nizaracianine Triflutate is unique because it offers a non-surgical approach through intravenous injections. Researchers are excited about this treatment because it potentially accelerates healing by directly enhancing tissue repair mechanisms at the site of injury. This novel approach could reduce the need for invasive procedures and promote quicker recovery times, making it a promising alternative to existing treatments.

What evidence suggests that Nizaracianine Triflutate is effective for ureteral injury?

Research has shown that Nizaracianine Triflutate, which participants in this trial may receive, helps surgeons see and avoid damaging the ureters during abdominopelvic surgery. Studies have found that this drug reduces the risk of accidental ureter injuries, which are the tubes connecting the kidneys to the bladder. Since ureters are difficult to see during surgery, the drug aids surgeons in quickly identifying and repairing any damage, potentially leading to shorter surgeries and better patient outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

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

Principal Investigator

Curadel Surgical Innovations, Inc. (CSI)

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

Principal Investigator

Curadel Surgical Innovations, Inc. (CSI)

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

Principal Investigator

Leiden University Medical Centre (LUMC)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

University Medical Center Groningen

Collaborator

Trials

770

Recruited

1,101,000+

Martini Hospital Groningen

Collaborator

Trials

32

Recruited

11,400+

Isala

Collaborator

Trials

91

Recruited

41,000+

Leiden University Medical Center

Collaborator

Trials

580

Recruited

623,000+

Citations

1. clinicaltrials.eu clinicaltrials.eu/inn/nizaracianine-triflutate/

Nizaracianine Triflutate: A Novel Drug for Ureter ... Reduced risk of accidental injury to the ureters. Quicker detection and repair of any ureter damage. Potentially shorter surgery times. Improved outcomes for ...

2. withpower.com withpower.com/trial/phase-2-and-3-injury-of-ureter-during-surgery-disorder-2024-49e25

Nizaracianine Triflutate for Ureteral Injury (TRIPHASE 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 ...

3. trialx.com trialx.com/clinical-trials/listings/292887/trial-to-visualize-the-ureters-with-nizaracianine-triflutate-in-adults-undergoing-abdominopelvic-surgery/

Trial to Visualize the Ureters With Nizaracianine Triflutate ... The goal of this clinical trial is to determine if the drug Nizaracianine Triflutate can help surgeons see and avoid the ureters during ...

4. clinicaltrials.eu clinicaltrials.eu/trial/study-on-ureter-imaging-with-nizaracianine-triflutate-for-patients-18-undergoing-abdominopelvic-surgery/

Study on Ureter Imaging with Nizaracianine Triflutate for ... This clinical trial investigates the efficacy and safety of nizaracianine triflutate in enhancing ureter visibility during abdominopelvic surgery in adults ...

5. synapse.patsnap.com synapse.patsnap.com/drug/d31d8012da7f4193a32d3e893b7022ed

Nizaracianine Triflutate - Drug Targets, Indications, Patents A Phase 2/3 randomized controlled semi-blinded trial to investigate safety and effectiveness in visualization of the ureters with nizaracianine triflutate, ...

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06101745/

Trial | NCT06101745 The goal of this clinical trial is to determine if the drug Nizaracianine Triflutate can help surgeons see and avoid the ureters during abdominopelvic ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/45/NCT04228445/Prot_004.pdf

An Open-Label, Randomized, Multicenter Study to ... Most studies of laparoscopic surgery with known risk for lower urinary tract injury have included an evaluation for the recognition of urinary tract injuries ...