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

Ureter Injury Clinical Trial

Official title:
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 Recruiting

Clinical Trial Summary

This study evaluates the safety and efficacy 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 efficacy 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	NCT05954767
Study type	Interventional
Source	Intuitive Surgical
Contact	Karen Hwang
Phone	1-800-876-1310
Email	karen.hwang@intusurg.com
Status	Recruiting
Phase	Phase 3
Start date	January 17, 2024
Completion date	July 2025

View Details

See also
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