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Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency
Sponsor: Prove pharm
Summary
This is a randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Bludigo when used as an aid in the determination of ureteral patency.
Official title: An Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, and Physician Satisfaction of Two Different Doses of Bludigo™ When Used as an Aid in the Determination of Ureteral Patency
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2023-10-12
Completion Date
2026-02-28
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
Indigotindisulfonate sodium 0.8%
Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.
Saline injection 0.9%
Placebo
Locations (1)
Albany Medical Center
Albany, New York, United States