A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery

Ureter Injury Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Ureter Injury

Clinical Trial Details

NCT number	NCT05769257
Study type	Interventional
Source	Intuitive Surgical
Contact
Status	Completed
Phase	Phase 2
Start date	June 14, 2023
Completion date	April 4, 2024

View Details

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