A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy

Ureter Injury Clinical Trial

Official title:
A Phase 2 Multi-Center Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging

Status Completed

Clinical Trial Summary

This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for the identified optimal dose in study participants.

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. Stage A will be a dose-escalation to determine the optimal dose for ureter visualization and Stage B will be an expanded safety and efficacy evaluation of the optimal dose. Stage B will include a no-drug safety control to evaluate the effects of surgery alone on the safety parameters of the study. ;

Study Design

Related Conditions & MeSH terms

Ureter Injury

Clinical Trial Details

NCT number	NCT03937505
Study type	Interventional
Source	Intuitive Surgical
Contact
Status	Completed
Phase	Phase 2
Start date	May 28, 2019
Completion date	July 22, 2021

View Details

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