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

STUDY OVERVIEW

This study sponsored by Intuitive Surgical assesses the safety and effectiveness of IS-001 administered intravenously to enhance the visualization of the ureter during robotic-assisted surgery using the da Vinci® Surgical System and Firefly® imaging, aiming to address the common issue of ureter injury during pelvic and abdominal procedures.

STUDY GOALS

The study aims to evaluate the safety and efficacy of intravenous IS-001 injection in aiding intraoperative ureter delineation during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.

LOCATION

El Paso, Texas: The Hospitals of Providence System

INCLUSION CRITERIA

  • Females aged 18 to 75 scheduled for robotic-assisted gynecological surgery using a da Vinci® system with Firefly® imaging.

  • Able and willing to give informed consent.

exclusion criteria

  • Pregnant or breastfeeding.

  • Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

  • Currently enrolled in another drug or device study within the last 6 months.

  • Any condition that may interfere with data collection or poses safety concerns, as determined by the investigator.

  • Known or suspected allergy to indocyanine green (ICG).

  • Abnormal screening laboratory values: eGFR < 60 mL/min/1.73 m^2, AST/SGOT ≥ 2.5 × ULN, ALT/SGPT ≥ 2.5 × ULN.

For more information, visit ClinicalTrials.gov.