IS-001 injection helps see ureters during robot-assisted colorectal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional study tests whether IV IS-001 improves intraoperative visualization of the ureters when using the da Vinci Surgical System with Firefly imaging during robotic-assisted colectomy. Participants are adults aged 16 to 75 undergoing robotic-assisted colectomy and have specific safety criteria to minimize risk. The trial assesses safety and efficacy of IS-001 in enhancing ureter delineation to reduce intraoperative injury. Sites include Hoag Memorial Hospital Presbyterian, Yale New Haven Hospital, and Orlando Health, with Intuitive Surgical as lead sponsor. Enrollment and eligibility focus on patients without significant hepatic impairment, kidney function within safe limits, and no conflicting conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• Orlando Health
  Orlando, Florida, United States Recruiting
• Mountain View Hospital
  Las Vegas, Nevada, United States Recruiting
• St David's North Austin Medical Center
  Austin, Texas, United States Recruiting
• HCA Houston Healthcare Medical Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Clinical Project Manager
• Email: info.is-001@intusurg.com
• Phone: 4085232100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.