Phase 3 Study of Filricianine IS-001 Injection for Improving Ureter Visualization During Robotic-Assisted Colorectal Surgery Using da Vinci Surgical System with Firefly Imaging

What this Trial Is About

This research aims to evaluate the safety and effectiveness of intravenous IS-001 injection to help surgeons better see the ureter during robotic-assisted colorectal surgery. The study addresses the common and serious complication of ureter injury during pelvic and abdominal surgeries, which often goes unnoticed during the operation. The investigation uses the da Vinci Surgical System with Firefly fluorescence imaging to improve visualization. Participants are patients aged 16 to 75 scheduled for robotic-assisted colectomy using this surgical system. Participants will receive two intravenous injections of IS-001 filricianine during surgery. Ureter visualization and delineation will be compared between standard white light and near-infrared imaging after each injection. The study monitors how well the ureter can be seen using these imaging methods and assesses the contrast of the fluorescent signal to improve surgeon guidance. The injections and imaging occur intraoperatively to aid ureter identification. Throughout the surgery, assessments include independent reader ratings of ureter visibility using a 1 to 5 Likert scale at various time points after injections. Researchers also measure the length of ureter delineation and compare surgeon and independent assessments. Safety and efficacy are monitored through these evaluations during and shortly after the injections. The study spans from screening to surgery with assessments completed during the procedure, aiming for improved ureter visualization to prevent injury.

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