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First received: August 30, 2023

Clinical Trial: Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency

Study Status: Completed

Recruit Status: RECRUITING

Condition: Ureter Injury

Study Type: INTERVENTIONAL


Official Title: An Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, and Physician Satisfaction of Two Different Doses of Bludigo™ (Indigotindisulfonate Sodium Injection, USP) 0.8% When Used

Brief 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™ (indigotindisulfonate Sodium Injection, USP) 0.8% when used as an aid in the determination of ureteral patency.Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure, age 18 to 85 years inclusive, will be screened for participation.Screening will occur within 30 days before study drug administration (Day of…

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