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RECRUITING
NCT07346066
PHASE3

IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery

Sponsor: Intuitive Surgical

View on ClinicalTrials.gov

Summary

This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation

Official title: A Phase 3 Multi-Center Efficacy Study of Filricianine Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci Surgical System With Firefly® Fluorescence Imaging

Key Details

Gender

All

Age Range

16 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

146

Start Date

2026-05-14

Completion Date

2027-08-31

Last Updated

2026-08-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

filricianine

IV injection of IS-001 filricianine with near infrared (NIR) imaging

Locations (9)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Orlando Health

Orlando, Florida, United States

Mountain View Hospital

Las Vegas, Nevada, United States

The Ohio State Unversity

Columbus, Ohio, United States

Kettering Health

Kettering, Ohio, United States

St David's North Austin Medical Center

Austin, Texas, United States

HCA Houston Healthcare Medical Center

Houston, Texas, United States

MultiCare Tacoma General Hospital

Tacoma, Washington, United States