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A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery
NCT05754333 · View on ClinicalTrials.gov ↗
Study Summary
The ureter was the tube that carries urine from the kidneys to the bladder. It was difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious. This study was about a potential new medical dye, called ASP5354. This dye was injected into the person at the start of surgery and was detected in the ureter. This was done by an imaging machine which had an option called near infrared fluorescence, or NIR-F. Together they showed live images of specific parts of the body. In this study, ASP5354 was used with an imaging machine with a NIR-F option to show live images of the ureter during surgery. People with kidneys that work properly and those with kidney problems could take part. The main aim of the study was to find out how clearly the ureter could be seen with ASP5354 during surgery in adults whose kidneys work properly or who have mild kidney problems. To do this, the surgeons injected ASP5354 into the person having surgery. Then, the surgeons compared images of the ureter with an imaging machine using normal white light and with the NIR-F option. Imaging using normal white light was the standard way surgeons see the ureter during surgery. People 12 years or older who were going to have certain abdominal surgeries could take part. Everyone taking part received ASP5354 during surgery, but how the imaging was done depended on which group they are in. Before surgery, the adults taking part whose kidneys work properly or who have mild kidney problems were assigned into 1 of 2 groups by chance alone. Images of the ureter were checked in 1 group using normal white light and the other group using normal white light and NIR-F. People 18 years and older with more severe kidney problems and all people under 18 years old were not be assigned to 1 of 2 groups: all images of the ureter were checked using normal white light and NIR-F. At the start of surgery, the surgeon injected ASP5354 into the per
Conditions Studied
Interventions
- DRUG pudexacianinium chloride
Study Locations (6)
Florida
- AdventHealth Orlando — Orlando
- Advent Health Tampa — Tampa
- Cleveland Clinic Florida — Weston
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
New York
- Icahn School of Medicine at Mount Sinai — New York
Texas
- M.D. Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2023-08-02 |
| Est. Completion | 2025-01-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05754333
The ClinicalTrials.gov registry entry for NCT05754333 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Intraoperative Ureter Visualization appearing as the primary indexed condition, and to 1 intervention — of which pudexacianinium chloride is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05754333 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Florida, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05754333 about?
NCT05754333 is a clinical study titled "A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery". The ureter was the tube that carries urine from the kidneys to the bladder. It was difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious. This study was about a potential new medical dye, called ASP5354. This ...
What is the current status of trial NCT05754333?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2023-08-02. Estimated completion is 2025-01-16.
What conditions does trial NCT05754333 study?
This clinical trial studies the following conditions: Intraoperative Ureter Visualization, Abdominolpelvic Surgery. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05754333?
The interventions under investigation include: pudexacianinium chloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05754333?
This trial is sponsored by Astellas Pharma Global Development, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05754333 being conducted?
This trial has 6 study locations across Florida, Illinois, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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