3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency

Exclusion Criteria

• •Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR \<30 mL/min/1.73m2 (using the MDRD) or need for dialysis in the near future, or having only 1 kidney.
• •Subjects with known severe hypersensitivity reactions to IC or other dyes including contrast agents.
• •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.