Skip to main content
OpenTrials
Completed

NCT Number: NCT05954767

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ureter Injury

Age range

16 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States

Loading trial locations.

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 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

  • Female subject is between the ages of 16 and 75, inclusive at time of consent.
  • Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® Surgical System with Firefly® Fluorescence Imaging.
  • Subject and/or subject's parent/guardian is willing and able to provide informed consent and/or assent as applicable.

Exclusion criteria

  • Subject is pregnant or nursing.
  • Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
  • Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
  • Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
  • Subject has any of the following screening laboratory values:
  • eGFR < 60 mL/min/1.73 m^2
  • Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × ULN
  • Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × ULN.
  • Planned use of CYTALUX™ (pafolacianine) for surgery

Treatment and study plan

IS-001

Drug

IV injection of IS-001 drug substance 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

    Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after 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 minutes

    Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after 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: 10

    Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after injection

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

    Time frame: 30

    Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after injection

  3. 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: 10 minutes

    Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after 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

    Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after 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

    Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection

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

    Time frame: 45 minutes

    Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection

  7. 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: 45 minutes

    Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection

  8. Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode

    Time frame: 10 minutes

    Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.

  9. Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode

    Time frame: 30 minutes

    Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.

  10. Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode

    Time frame: 45 minutes

    Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.

  11. concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

    Time frame: 10 minutes

    Determine degree of concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment at (a) the pelvic brim location and (b) the uterine arteries location

  12. concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

    Time frame: 30 minutes

    Determine degree of concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment at (a) the pelvic brim location and (b) the uterine arteries location

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

    Time frame: 45 minutes

    Determine degree of concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment at (a) the pelvic brim location and (b) the uterine arteries location

  14. Determine degree of concordance of ureter visualization between independent readers

    Time frame: 10 minutes

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

  15. Determine degree of concordance of ureter visualization between independent readers

    Time frame: 30 minutes

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

  16. Determine degree of concordance of ureter visualization between independent readers

    Time frame: 45 minutes

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

  17. degree of concordance of ureter visualization within independent readers

    Time frame: 10 minutes

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

  18. degree of concordance of ureter visualization within independent readers

    Time frame: 30 minutes

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

  19. degree of concordance of ureter visualization within independent readers

    Time frame: 45 minutes

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

Other 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 after second injection

    Time frame: 10 minutes

    Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging compared white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes

  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 after second injection

    Time frame: 30 minutes

    Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging compared white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes

  3. 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 after second injection

    Time frame: 45 minutes

    Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging compared white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes

  4. Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection

    Time frame: 10 minutes

    Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode after second injection for procedures lasting longer than 60 minutes

  5. Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection

    Time frame: 30 minutes

    Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode after second injection for procedures lasting longer than 60 minutes.

  6. Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection

    Time frame: 45 minutes

    Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode after second injection for procedures lasting longer than 60 minutes.

  7. 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 - 2nd injection

    Time frame: 10 minutes

    Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging over white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes

  8. 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 - 2nd injection

    Time frame: 30 minutes

    Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging over white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes

  9. 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 - 2nd injection

    Time frame: 45 minutes

    Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging over white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

A Phase 3 Multi-Center Efficacy Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2023
Registry last updated
Jan 15, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.