A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery

A Phase 2 Multi-Center Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging

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

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 feasibility of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.

Inclusion Criteria:

1. Male and female subjects between the ages of 18 and 75, inclusive
2. Subject is scheduled to undergo robotic-assisted rectal, sigmoid, or left colon resection surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging

Exclusion Criteria:

1. Subject is pregnant or nursing

2. Subject has known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

3. Subject has any of the following screening laboratory values:

   1. eGFR < 60 mL/min/1.73 m^2
   2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
   3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN

4. Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months

5. 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

6. Subjects with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used.