Study Details

A study to find out if ASP5354 can clearly help show the ureter during surgery in people with or without kidney disease

This trial will be recruiting
The study has not started recruiting participants.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT05999747

Astellas Study ID

The unique identification code given by the study sponsor.

5354-CL-0303

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

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

18 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

Sep 2023 - Mar 2024

Masking

None (Open Label)

Enrollment number

91

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 Adult Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries

Study summary

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