IS-001 Injection for Ureteral Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
Are You a Good Fit for This Trial?
This trial is for males and females aged 16 to 75 who are scheduled for robotic-assisted colon surgery using the da Vinci X/Xi system with special fluorescence imaging.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- IS-001 (filricianine)
Trial Overview
The study is testing an intravenous injection called IS-001 (filricianine) to see if it safely helps surgeons better see and avoid the ureters during colorectal surgery. The focus is on safety and effectiveness.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Ureter visualization and delineation will be compared between white light (standard of care) and near-infrared (NIR) imaging mode after each of the two single intravenous injections of IS-001.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Intuitive Surgical
Lead Sponsor
Gary Guthart
Intuitive Surgical
Chief Executive Officer since 2010
PhD in Engineering, California Institute of Technology
Henry Charlton
Intuitive Surgical
Chief Medical Officer since 2023
MD from an unspecified institution
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