Study on Ureter Imaging with Nizaracianine Triflutate for Patients 18+ Undergoing Abdominopelvic Surgery

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What is this study about?

This clinical trial is focused on improving the visualization of the ureters, which are tubes that carry urine from the kidneys to the bladder, during certain types of surgeries in the abdomen and pelvis. The study involves the use of a special medication called nizaracianine triflutate, which is given through an injection into a vein. This medication is designed to help surgeons see the ureters more clearly by using a special type of light called near-infrared fluorescent light. The trial aims to determine how safe and effective this medication is in helping surgeons identify the ureters during surgery.

Participants in the study will receive the medication in up to three doses while they are undergoing surgery. The study will compare the results with those of a placebo group to assess the benefits of using nizaracianine triflutate. The goal is to find the best dose that provides a clear view of the ureters without causing any harm to the patients. This could potentially make surgeries safer by reducing the risk of accidental damage to the ureters.

In addition to nizaracianine triflutate, the study also uses a solution called Glucose 5%, which is a common sterile fluid used in medical settings. The trial will monitor how well the medication works in helping surgeons see the ureters and whether it can reduce the need for more invasive procedures during surgery. The study is open to adults aged 18 and older who are scheduled for certain types of abdominal or pelvic surgeries.

1 joining the trial

Upon joining the trial, eligibility is confirmed based on criteria such as age (18 years or older) and the need for a specific type of surgery.

Informed consent is required before any trial-specific procedures begin.

2 pre-surgery preparation

Before surgery, a negative pregnancy test is required for women of childbearing potential.

Screening laboratory tests are conducted to ensure results are within normal limits or deemed clinically insignificant.

3 administration of medication

The medication nizaracianine triflutate is administered intravenously in up to three divided doses.

The purpose of the medication is to enhance the visualization of the ureters during surgery using near-infrared (NIR) fluorescent light.

4 surgical procedure

The surgical procedure involves the visualization of the ureters, which is facilitated by the administered medication.

The procedure may be open or minimally invasive, including robotic surgery.

5 post-surgery assessment

After surgery, the effectiveness of the medication in enhancing ureter visualization is assessed.

Safety assessments are conducted to monitor any adverse effects of the medication.

6 follow-up

Follow-up visits may be scheduled to further assess the safety and effectiveness of the medication.

The trial aims to determine the near-optimal dose of nizaracianine triflutate for future use.

Who Can Join the Study?

Must be 18 years old or older.
Scheduled to have a necessary abdominopelvic surgical procedure. This is a surgery in the area of the abdomen and pelvis.
For Phase 2, the surgery should last at least 2 hours and involve working on one or both ureters. Ureters are tubes that carry urine from the kidneys to the bladder.
For Phase 3, the surgery can be of any length, but one or more ureters should be seen during the procedure.
The surgery can be open (traditional) or MIS (minimally invasive surgery), which includes robotic surgery.
Both ureters should be present and working properly.
Must be able and willing to give informed consent before any study-specific procedures. This means understanding and agreeing to participate in the study.
Results from initial laboratory tests should be normal, or if not, they should be considered not important for health by the study doctors.
Women who can have children must have a negative pregnancy test.

Who Cannot Join the Study?

Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means groups that might need special protection or care.
Patients who have any medical conditions that could interfere with the study, such as issues with urinary tract imaging.
Patients who are not able to follow the study procedures or instructions.
Patients who have any other health conditions that the study doctors think might make it unsafe for them to participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
Isala Klinieken Stichting	Zwolle	The Netherlands
Uhffcitghcbb Mqztiyv Czgvcty Gooeznwop	Groningen	The Netherlands
Sdpphxydj Mlihsyd Zzzrpkvdds	Groningen	The Netherlands
Eyzfuci Utgkucimmgys Mzxlspx Cvrivlx Rrfavsugg (lfmdmvc Mit	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	02.10.2023

Trial locations

Investigated drugs:

Nizaracianine Triflutate

Nizaracianine is a medication being tested in this clinical trial. It is given through an intravenous injection and is used to help doctors see the ureters more clearly during certain types of surgeries in the abdomen and pelvis. The medication works by using a special type of light called near-infrared (NIR) fluorescent light, which makes the ureters glow and easier to identify. This can help surgeons avoid damaging the ureters during surgery. The trial is focused on checking how safe and effective this medication is and finding the best dose to use for this purpose.

Urinary Tract Imaging – This is not a disease but a diagnostic procedure used to visualize the urinary tract, including the kidneys, ureters, bladder, and urethra. It helps in identifying abnormalities such as blockages, stones, or structural issues. The imaging can be done using various techniques like X-rays, CT scans, or MRIs. During the procedure, a contrast dye may be used to enhance the visibility of the urinary tract structures. This process is crucial for planning surgeries or other medical interventions. It provides detailed images that assist healthcare providers in diagnosing and managing urinary tract conditions.

Trial ID:

2023-503241-63-00

Protocol code:

ZW800-001

Trial Phase:

Therapeutic use (Phase IV)

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Study on Ureter Imaging with Nizaracianine Triflutate for Patients 18+ Undergoing Abdominopelvic Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?