Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery

Inclusion criteria

• Provide written informed consent prior to the initiation of study procedures
• Are > 18 years of age
• Women consented to undergo standard of care minimally invasive pelvic surgery (traditional laparoscopy and robotic surgery)
• Women who are expected to be admitted to the hospital following surgery for at least 24 hours

Exclusion criteria

• Are unwilling or unable to provide informed consent.
• Are unwilling or unable to comply with the requirements of the protocol.
• History of prior urologic surgery.
• History of prior pelvic surgery.
• History of known retroperitoneal fibrosis.
• Have any of the following screening laboratory values:

• Hemoglobin ≤ 8.0 g/dL;
• Absolute neutrophil count (ANC) ≤ 1500/μL;
• Platelet count ≤ 100,000/μL;
• Serum creatinine ≥ 1.5 x the institutional upper limit of normal (IULN) creatinine;
• Serum bilirubin ≥ 1.5 x IULN;
• Aspartate transaminase (AST or serum glutamic oxaloacetic transaminase, SGOT) ≥ 2x IULN;• Alanine transaminase (ALT or serum glutamate pyruvate transaminase, SGPT) ≥ 2 x IULN.
• Females who are pregnant, lactating, or breastfeeding;
• Any other condition that, in the Investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy.