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NCT04238481 · ClinicalTrials.gov registry record · Phase 2
A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery
A Phase 2 study of Laparoscopic/Minimally Invasive Colorectal Surgery, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
- 2
- Study locations
NCT04238481: Completed Phase 2 study of Laparoscopic/Minimally Invasive Colorectal Surgery, sponsored by Astellas Pharma.
NCT04238481 is a Phase 2 study of Laparoscopic/Minimally Invasive Colorectal Surgery that has completed, run by Astellas Pharma. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04238481, a Phase 2 study of Laparoscopic/Minimally Invasive Colorectal Surgery, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
The anatomical visualization of the index ureter(s) was assessed by the investigator intraoperatively using a binary "Yes or No" question on the ability to visualize the ureter and was assessed as successful, if both 30 minutes after pudexacianinium chloride dosing and at end of surgery the visualization was assessed as positive (Yes)/successful. For imputation of missing values at 30 minutes after pudexacianinium chloride administration, the nearest time points before and after the 30 minutes w
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 |
What the finished NCT04238481 record still lists
NCT04238481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
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.
NCT04238481 reports a single indexed study location in Florida, Louisiana.
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.
What interventions are being tested in trial NCT04238481?
The interventions under investigation include: Pudexacianinium chloride (DRUG).
Who is sponsoring clinical trial NCT04238481?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04238481's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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