Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Patient's With Renal Impairment

Eligibility 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.
• * An estimated glomerular filtration rate (eGFR) at baseline will be determined using the Modification of Diet in Renal Disease formula (MDRD) and standardized by using individual's body surface area.
• * Normal subjects: eGFR of ≥90 mL/min
• * Mild renal impairment: eGFR 60 to 89 mL/min
• * Moderate renal impairment: eGFR 30 to 59 mL/min
• * Severe renal impairment: eGFR 15 to 29 mL/min
• * Subjects with eGFR \<15 mL/min or expected 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