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

RecruitingPhase 3

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

Who can join

Ages 16 to 75 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Male and female participants between the ages of 16 and 75, inclusive
2. Participant is scheduled to undergo robotic-assisted colectomy using the da Vinci X/Xi Surgical System with SFF Fluorescence Imaging Exclusion Criteria

1\. Participant is pregnant or nursing 2. Participant has known current acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 3. Participant has any of the following screening laboratory values: eGFR \< 30 mL/min/1.73 m2

1. Aspartate aminotransferase (AST) ≥ 2.5 × ULN
2. Alanine aminotransferase (ALT) ≥ 2.5 × ULN
3. Total Bilirubin \> 2mg/dL 4. Participant has any concomitant non-colorectal cancer 5. Participant has any circumstances that, in the judgment of the Investigator, might make them not a suitable candidate for the study 6. Participants have already been enrolled in another investigational drug or device study within the past 6 months 7. Participants with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used 8. Participant is expected to receive or has received other methods for ureter identification during the surgery (e.g., ureteral stent placement, illuminated catheters, retrograde ICG injections) before the administration of IS-001 9. The duration of the surgery is expected to be less than 90 minutes as determined during preoperative planning.

About the study

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

What is being tested

Sponsor: Intuitive Surgical · Participants: 146 · Started: May 14, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07346066

Locations in the U.S.

CaliforniaHoag Memorial Hospital Presbyterian, Newport Beach
ConnecticutYale New Haven Hospital, New Haven
FloridaOrlando Health, Orlando
NevadaMountain View Hospital, Las Vegas
OhioThe Ohio State Unversity, Columbus (Not yet recruiting)
Kettering Health, Kettering (Not yet recruiting)
TexasSt David's North Austin Medical Center, Austin
HCA Houston Healthcare Medical Center, Houston
WashingtonMultiCare Tacoma General Hospital, Tacoma (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.