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NCT Number: NCT07346066

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

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

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Key information

Conditions

Ureter Injury

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted colorectal surgery with the da Vinci® Surgical System and Firefly® imaging.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

filricianine

Drug

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

Primary outcomes

  1. 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.

    Time frame: 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.

Secondary outcomes

  1. Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length

    Time frame: 30 minutes after the first injection

    Evaluate ureter length delineation at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the first IS-001 injection

  2. 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

    Time frame: 30 miinutes after second injection

    Evaluate ureter visualization by each independent reader at (a) PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the second IS-001 injection

  3. Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length

    Time frame: 30 minutes after second injection

    Evaluate ureter length delineation at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the second IS-001 injection

  4. Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible

    Time frame: 30 minutes after first IS-001 injection

    Evaluate ureter visualization based on the intra-operative surgeon's rating at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 30 minutes after the first IS-001 injection

  5. 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.

    Time frame: 45 minutes after first injection

    Evaluate ureter visualization by each independent reader at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 45 minutes after the first and second IS-001injection

  6. 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

    Time frame: 45 minutes after second injection

    Evaluate ureter visualization by each independent reader at (a) the PB and (b) IMA locations in SFF mode compared to white light mode up to 45 minutes after the first and second IS-001injection

  7. Concordance of ureter visualization between independent readers

    Time frame: 10 minutes after first injection

    Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location

  8. Concordance of ureter visualization between independent readers

    Time frame: 30 minutes after first injection

    Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location

  9. Concordance of ureter visualization between independent readers

    Time frame: 45 minutes after first injection

    Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location

  10. Concordance of ureter visualization between independent readers

    Time frame: 10 minutes after second injection

    Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location

  11. Concordance of ureter visualization between independent readers

    Time frame: 30 minutes after second injection

    Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location

  12. Concordance of ureter visualization between independent readers

    Time frame: 45 minutes after second injection

    Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim and (b) the IMA location

  13. Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

    Time frame: 10 minutes after first injection

    Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment

  14. Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

    Time frame: 30 minutes after first injection

    Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment

  15. Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

    Time frame: 45 minutes after first injection

    Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment

  16. Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

    Time frame: 10 minutes after second injection

    Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment

  17. Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

    Time frame: 30 minutes after second injection

    Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment

  18. Concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

    Time frame: 45 minutes after second injection

    Determine the degree of concordance between the intra-operative ureter visualization assessment and the independent reader ureter visualization assessment

  19. Degree of concordance of ureter visualization within independent readers

    Time frame: 10 minutes after first injection

    Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location

  20. Degree of concordance of ureter visualization within independent readers

    Time frame: 30 minutes after first injection

    Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location

  21. Degree of concordance of ureter visualization within independent readers

    Time frame: 45 minutes after first injection

    Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location

  22. Degree of concordance of ureter visualization within independent readers

    Time frame: 10 minutes after second injection

    Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location

  23. Degree of concordance of ureter visualization within independent readers

    Time frame: 30 minutes after second injection

    Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location

  24. Degree of concordance of ureter visualization within independent readers

    Time frame: 45 minutes after second injection

    Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim and (b) IMA location

  25. Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode

    Time frame: 10 minutes after first injection

    Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location

  26. Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode

    Time frame: 30 minutes after first injection

    Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location

  27. Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode

    Time frame: 45 minutes after first injection

    Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location

  28. Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode

    Time frame: 10 minutes after second injection

    Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location

  29. Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode

    Time frame: 30 minutes after second injection

    Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location

  30. Ureter signal-to-background ratio evaluating contrast of fluorescent signal in NIR imaging mode

    Time frame: 45 minutes after second injection

    Evaluate ureter signal-to-background ratio in Firefly imaging at (a) the pelvic brim and (b) the IMA location

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Project Manager

CONTACT

[email protected]

4085232100

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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