A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery
Public ClinicalTrials.gov record NCT05754333. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 With Near Infrared Fluorescence (NIR-F) Imaging in Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries
Study identification
- NCT ID
- NCT05754333
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Industry
- Enrollment
- 107 participants
Conditions and interventions
Interventions
- pudexacianinium chloride Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 1, 2023
- Primary completion
- Dec 16, 2024
- Completion
- Jan 15, 2025
- Last update posted
- Oct 8, 2025
2023 – 2025
United States locations
- U.S. sites
- 6
- U.S. states
- 4
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Advent Health Tampa | Tampa | Florida | 33613 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05754333, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2025 · Synced May 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05754333 live on ClinicalTrials.gov.