IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery

Status: complete

This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.

Female subject is between the ages of 16 and 75, inclusive at time of consent.
Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® Surgical System with Firefly® Fluorescence Imaging.
Subject and/or subject's parent/guardian is willing and able to provide informed consent and/or assent as applicable.

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:
eGFR < 60 mL/min/1.73 m^2
Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × ULN
Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × ULN.
Planned use of CYTALUX™ (pafolacianine) for surgery

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.

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