146 Participants NeededMy employer runs this trial

IS-001 Injection for Ureteral Injury

Recruiting at 8 trial locations
CP
Overseen ByClinical Project Manager
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Intuitive Surgical
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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

I am scheduled for a robotic colectomy using the da Vinci X/Xi system with SFF imaging.
I am between 16 and 75 years old.

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

Group I: IS-001 InjectionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Intuitive Surgical

Lead Sponsor

Trials
80
Recruited
49,600+

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