NCT05954767

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

A Phase 3 Multi-Center Efficacy Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: Female
• 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 surgery with the da Vinci® Surgical System and Firefly® imaging.

Conditions

• Ureter Injury

Interventions

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

Timeline

• Start date: 2024-01-17
• Primary completion: 2025-01-31
• Completion: 2025-09-29
• First posted: 2023-07-20
• Last updated: 2026-01-15

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study