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A study to find out if ASP5354 can clearly help show the ureter during surgery

This trial is recruiting
The study is currently recruiting participants.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT05754333

Astellas Study ID

The unique identification code given by the study sponsor.

5354-CL-0301

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

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Condition

Ureter visualization, Lower abdominal surgery

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

12 Years - N/A

Sex

Female & Male

Product

ASP5354

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jun 2023 - Jan 2024

Masking

None (Open Label)

Enrollment number

104

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 summary

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Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, United States, 60611

Recruiting
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AdventHealth Orlando

Orlando, United States, 32803

Recruiting
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