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

Last updated: January 14, 2026
Sponsor: Intuitive Surgical
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

IS-001

Clinical Study ID

NCT05954767
ISI-124804-3
  • Ages 16-75
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Female subject is between the ages of 16 and 75, inclusive at time of consent.

  2. Subject is scheduled to undergo robotic-assisted gynecological procedure using a daVinci® Surgical System with Firefly® Fluorescence Imaging.

  3. Subject and/or subject's parent/guardian is willing and able to provide informedconsent and/or assent as applicable.

Exclusion

Exclusion Criteria:

  1. Subject is pregnant or nursing.

  2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV)infection.

  3. Subject is already enrolled in another investigational drug or device studyreceiving therapeutic agents within the past 6 months

  4. Subject has any other condition or personal circumstance that, in the judgment ofthe Investigator, might interfere with the collection of complete quality data orrepresents an unacceptable safety profile

  5. Subject has a known or suspected hypersensitivity to indocyanine green (ICG)

  6. Subject has any of the following screening laboratory values:

  7. eGFR < 60 mL/min/1.73 m^2

  8. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × ULN

  9. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × ULN.

  10. Planned use of CYTALUX™ (pafolacianine) for surgery

Study Design

Total Participants: 189
Treatment Group(s): 1
Primary Treatment: IS-001
Phase: 3
Study Start date:
January 17, 2024
Estimated Completion Date:
September 29, 2025

Study Description

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.

Connect with a study center

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California 92663
    United States

    Site Not Available

  • Hoag Memorial Hospital Presbyterian

    Newport Beach 5376890, California 5332921 92663
    United States

    Site Not Available

  • HCA Mercy Hospital

    Miami, Florida 33133
    United States

    Site Not Available

  • Orlando Health

    Orlando, Florida 32806
    United States

    Site Not Available

  • HCA Mercy Hospital

    Miami 4164138, Florida 4155751 33133
    United States

    Site Not Available

  • Orlando Health

    Orlando 4167147, Florida 4155751 32806
    United States

    Site Not Available

  • E.W. Sparrow Hospital

    Lansing, Michigan 48912
    United States

    Site Not Available

  • E.W. Sparrow Hospital

    Lansing 4998830, Michigan 5001836 48912
    United States

    Site Not Available

  • MountainView Hospital

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • MountainView Hospital

    Las Vegas 5506956, Nevada 5509151 89128
    United States

    Site Not Available

  • OhioHealth

    Columbus, Ohio 43214
    United States

    Site Not Available

  • The Ohio State Unversity

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • OhioHealth

    Columbus 4509177, Ohio 5165418 43214
    United States

    Site Not Available

  • The Ohio State Unversity

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • St. David's Surgical Hospital

    Austin, Texas 78681
    United States

    Site Not Available

  • The Hospital of Providence Transmountain Campus

    El Paso, Texas 79911
    United States

    Site Not Available

  • St. David's Surgical Hospital

    Austin 4671654, Texas 4736286 78681
    United States

    Site Not Available

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