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…
Read more