Overview
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.
Description
Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.
Eligibility
Inclusion Criteria:
Inclusion Criteria
- Female subject is between the ages of 18 and 75, inclusive.
- Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® surgical system with Firefly® fluorescent imaging.
- Subject is willing and able to provide informed consent.
Exclusion Criteria:
- Subject is pregnant or nursing.
- Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
- Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile.
- Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
- Subject has any of the following screening laboratory values:
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2
- Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × upper limit normal (ULN)
- Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × upper limit normal (ULN).