Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Recruiting NCT05640115 - Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent Early Phase 1
Recruiting NCT06054880 - Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency Phase 4
Completed NCT03937505 - A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Phase 2
Recruiting NCT06278753 - Comparison of Standard Cystoscopy With Carbon Dioxide Cystoscopy
Recruiting NCT05954767 - IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery Phase 3
Completed NCT04228445 - 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency Phase 3
Recruiting NCT06085183 - Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Patient's With Renal Impairment Phase 4
Completed NCT03387410 - Ureter Identification With IRDye 800BK Phase 1/Phase 2