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

Recruiting now · Phase 3

Conditions studied: Ureter Injury

In brief

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

Key facts

Study ID

NCT07346066

Run by

Intuitive Surgical

People needed

146

Starts

2026-05-14

Expected to finish

2027-08-31

Last updated by the study team

2026-08-05

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female participants between the ages of 16 and 75, inclusive
• Participant is scheduled to undergo robotic-assisted colectomy using the da Vinci X/Xi Surgical System with SFF Fluorescence Imaging Exclusion Criteria
• 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
• Aspartate aminotransferase (AST) ≥ 2.5 × ULN
• Alanine aminotransferase (ALT) ≥ 2.5 × ULN
• 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.

Where it is running

• St David's North Austin Medical Center — Austin, Texas, United States (enrolling)
• HCA Houston Healthcare Medical Center — Houston, Texas, United States (enrolling)
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
• Mountain View Hospital — Las Vegas, Nevada, United States (enrolling)
• Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• Orlando Health — Orlando, Florida, United States (enrolling)
• MultiCare Tacoma General Hospital — Tacoma, Washington, United States
• The Ohio State Unversity — Columbus, Ohio, United States
• Kettering Health — Kettering, Ohio, United States

Full record on ClinicalTrials.gov

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