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A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery in People With or Without Kidney Disease
NCT05999747 · View on ClinicalTrials.gov ↗
Study Summary
The ureter is the tube that carries urine from the kidneys to the bladder. It is 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 is about a potential new medical dye, called ASP5354. This dye is injected into the person at the start of surgery and is detected in the ureter. This is done by an imaging machine which has an option called near infrared fluorescence, or NIR-F. Together they show live images of specific parts of the body. In this study, ASP5354 is 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 can take part in this study. The main goal of the study is to find out how clearly the ureter can be seen with ASP5354 during surgery in people whose kidneys work properly or who have mild kidney problems. To do this, the surgeons will inject ASP5354 into the person having surgery. Then, the surgeons will compare images of the ureter with an imaging machine using normal white light and with the NIR-F option. Imaging using normal white light is the standard way surgeons see the ureter during surgery. People 18 years or older, with or without kidney disease, who were going to have certain abdominal surgeries may be able to take part. Everyone taking part will receive ASP5354 during surgery, but how the imaging is done will depend on which group they are in. Before surgery, the people whose kidneys work properly or who have mild kidney problems will be assigned into 1 of 2 groups by chance alone. Images of the ureter will be checked in 1 group using normal white light and the other group using normal white light and NIR-F. People with more severe kidney problems will not be assigned to 1 of 2 groups: all images of the ureter will be checked using normal white light and NIR-F. At the start of surgery, the surgeon will inject ASP5354 into
Conditions Studied
Interventions
- DRUG pudexacianinium chloride
Study Locations (12)
California
- Cedars Sinai Medical Center — Los Angeles
- Hoag Memorial Hospital Presbyterian — Newport Beach
Florida
- University of South Florida — Tampa
- Cleveland Clinic Florida — Weston
North Carolina
- Duke University Hospital — Durham
- Firsthealth of the Carolinas INC — Pinehurst
Texas
- Baylor College of Medicine — Houston
- Houston Methodist Hospital — Houston
Missouri
- Washington University Center — St Louis
Nevada
- University of Nevada, Las Vegas — Las Vegas
Pennsylvania
- Temple University Hospital — Philadelphia
Washington
- Benaroya Research Institute at VA Mason — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2024-03-19 |
| Est. Completion | 2025-10-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05999747
The ClinicalTrials.gov registry entry for NCT05999747 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 95 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: NCT05999747 reports 12 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, North Carolina. 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 NCT05999747 about?
NCT05999747 is a clinical study titled "A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery in People With or Without Kidney Disease". The ureter is the tube that carries urine from the kidneys to the bladder. It is 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 is about a potential new medical dye, called ASP5354. This dy...
What is the current status of trial NCT05999747?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2024-03-19. Estimated completion is 2025-10-13.
What conditions does trial NCT05999747 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 NCT05999747?
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 NCT05999747?
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 NCT05999747 being conducted?
This trial has 12 study locations across California, Florida, Missouri, Nevada, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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