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A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery
NCT04238481 · View on ClinicalTrials.gov ↗
Study Summary
The primary purpose of this study was to determine the optimal dose of ASP5354 for ureter visualization in participants undergoing laparoscopic/minimally invasive colorectal surgery This study also investigated the safety, tolerability and the pharmacokinetics of ASP5354 in participants undergoing laparoscopic/minimally invasive colorectal surgery.
Conditions Studied
Interventions
- DRUG Pudexacianinium chloride
Study Locations (2)
Florida
- Center for Colon and Rectal Surgery; AdventHealth Medical Group — Orlando
Louisiana
- Ochsner Medical Center — New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-10-06 |
| Est. Completion | 2021-11-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04238481
The ClinicalTrials.gov registry entry for NCT04238481 describes a study currently listed as completed. It is categorized as Phase 2, 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 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Laparoscopic/Minimally Invasive Colorectal Surgery 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: NCT04238481 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, Louisiana. 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 NCT04238481 about?
NCT04238481 is a clinical study titled "A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery". The primary purpose of this study was to determine the optimal dose of ASP5354 for ureter visualization in participants undergoing laparoscopic/minimally invasive colorectal surgery This study also investigated the safety, tolerability and the pharmacokinetics of ASP5354 in participants undergoing l...
What is the current status of trial NCT04238481?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2020-10-06. Estimated completion is 2021-11-29.
What conditions does trial NCT04238481 study?
This clinical trial studies the following conditions: Laparoscopic/Minimally Invasive Colorectal 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 NCT04238481?
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 NCT04238481?
This trial is sponsored by Astellas Pharma, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04238481 being conducted?
This trial has 2 study locations across Florida, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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