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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 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. The trial reports 2 study locations across 2 states.

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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.

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

FieldValue
Enrollment Target 13 participants
Start Date 2020-10-06
Est. Completion 2021-11-29
Phase Phase 2

Sponsor

Astellas Pharma

165 total trials

What the Registry Record Tells You About NCT04238481

The ClinicalTrials.gov registry entry for NCT04238481 describes a study currently listed as completed, categorized as Phase 2. 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 165 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.