NCT07346066

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

A Phase 3 Multi-Center Efficacy Study of Filricianine Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci Surgical System With Firefly® Fluorescence Imaging

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 colorectal surgery with the da Vinci® Surgical System and Firefly® imaging.

Conditions

• Ureter Injury

Interventions

Type	Name	Description
DRUG	filricianine	IV injection of IS-001 filricianine with near infrared (NIR) imaging

Timeline

• Start date: 2026-03-31
• Primary completion: 2027-04-30
• Completion: 2027-08-31
• First posted: 2026-01-16
• Last updated: 2026-01-16

Regulatory

• FDA-regulated drug study