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Recruiting Phase 3

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

NCT07346066 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-05-14
Last updated
2026-08-05

Condition(s) studied

Ureter Injury

Investigational drug(s) / intervention(s)

filricianine

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

Study summary

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

Eligibility

Sex
ALL
Min age
16 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible. — 10 minutes after first injection
    Evaluate ureter visualization by each independent reader at (a) the pelvic brim (PB) and (b) Inferior Mesenteric Artery (IMA) locations in Sensitive Firefly (SFF) mode compared to white light mode up to 30 minutes after the first IS-001 injection.

Trial sites (9)

FacilityCityRegionStatus
Hoag Memorial Hospital Presbyterian Newport Beach California Recruiting
Yale New Haven Hospital New Haven Connecticut Recruiting
Orlando Health Orlando Florida Recruiting
Mountain View Hospital Las Vegas Nevada Recruiting
The Ohio State Unversity Columbus Ohio Not Yet Recruiting
Kettering Health Kettering Ohio Not Yet Recruiting
St David's North Austin Medical Center Austin Texas Recruiting
HCA Houston Healthcare Medical Center Houston Texas Recruiting
MultiCare Tacoma General Hospital Tacoma Washington Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07346066 on ClinicalTrials.gov ↗ ← All trials in the USA