NCT05769257

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and feasibility 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 feasibility 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	Intravenous injection of IS-001 investigational drug

Timeline

• Start date: 2023-06-14
• Primary completion: 2024-03-18
• Completion: 2024-04-04
• First posted: 2023-03-15
• Last updated: 2024-05-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study