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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


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

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Completed NCT05769257 - A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery Phase 2
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