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

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two different doses (2.5 mL and 5.0 mL) of Bludigo, a contrast dye, to help determine if the ureter is open during surgery. This randomized, multicenter study includes adults aged 18 to 85 scheduled for surgery requiring ureter patency assessment by cystoscopy. The study aims to compare these doses and assess physician satisfaction with Bludigo as an aid in this process. Participants will be randomly assigned to receive either a low dose (2.5 mL) or high dose (5.0 mL) of Bludigo during surgery after initially receiving a saline injection as a control. The study uses an intra-patient controlled design where each subject serves as their own control. Subjects will be grouped based on body mass index (BMI) and followed with safety monitoring including adverse event tracking, laboratory tests, ECG, and vital signs. Participants will undergo screening within 30 days prior to surgery that includes medical history, physical exam, lab work, ECG, and vital signs. After surgery, there will be a follow-up visit 7 to 30 days later and a final phone call around day 30. Researchers will measure urine jet visibility 10 minutes after dosing, adverse events, clinical labs, vital signs, ECG changes, and physician satisfaction. Safety will be monitored during and after the procedure to assess outcomes over 30 days.

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