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

Inclusion Criteria

• Subjects between ≥ 18 and ≤ 85 years old
• Subjects who signed a written IRB approved, informed consent form
• Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure

Exclusion Criteria

• Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR \<30 mL/min (calculated using the MDRD formula and standardized by using individual's body surface area) or need for dialysis in the near future, or having only 1 kidney
• Subjects with known severe hypersensitivity reactions to Bludigo™ or other dyes, including contrast dyes
• Known history of drug or alcohol abuse within 6 months prior to the time of screening visit
• Subjects, as assessed by the Investigator, with conditions/concomitant diseases precluding their safe participation in this study (e.g. major systemic diseases)
• Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is uncooperative or has a condition that could lead to non-compliance with the study procedures
• Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
• Subjects with life expectancy \< 6 months
• Requirement for concomitant treatment that could bias primary evaluation.
• Subjects who are pregnant or breast-feeding